Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1119779

FEI Number

1119779

Entity Name

BECTON, DICKINSON & CO.

City/State/Country

SPARKS, MD, US

Establishment Address

7 LOVETON CIR., SPARKS, MD 21152, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K962210

PMA Number

N/A

All Registered Proprietary Names

BD BBL Sensi-Disc Cefiderocol 30 ?g BD Phoenix Automated Microbiology System - Ticarcillin GN 1-128 ?g/mL BD Phoenix Automated Microbiology System - Amoxicillin/Clavulanate GN 0.5/0.25-32/16 ?g/mL BD Phoenix Automated Microbiology System - Ampicillin/Sulbactam GN 0.5/0.25-32/16 ?g/mL BD BBL Sensi-Disc Cefepime 30 ?g BD Phoenix Automated Microbiology System - Ceftaroline GP 0625-4 ?g/mL BD BBL Sensi-Disc Streptomycin 300 ?g BD BBL Sensi-Disc Gentamicin 120 ?g Liquid Based Cytology Specimen (LBC) Dilution Tubes for the BD ProbeTec Qx Amplified DNA Assays BD Veritor InfoScan Module BD Veritor InfoSync Module BD Veritor InfoWifi Module BD Kiestra InoqulA+ BD Kiestra InoqulA+ TLA BD Kiestra InoqulA BD Kiestra InoqulA Track BD Kiestra Slide Processing Module BD Kiestra InoqulA Track with SPM BD Kiestra InoqulA with SPM BD BBL Sensi-Disc Tigecycline 15 µg BD BBL Sensi-Disc Trimethoprim 5 µg BD BBL Sensi-Disc Piperacillin 100 ?g BD Phoenix Automated Microbiology System - Oxacillin GP 0625-4 ?g/mL BD Phoenix Automated Microbiology System - Ampicillin/Sulbactam GP 2/1-32/16 ?g/mL BD BBL Lim Broth BD Phoenix Automated Microbiology System - Imipenem GN 0625-32 ?g/mL BD Phoenix Automated Microbiology System - Penicillin GP 0625-32 ?g/mL BD Phoenix Automated Microbiology System - Erythromycin Strep 0156-4 ?g/mL BD Phoenix Automated Microbiology System - Tetracycline Strep 0625-16 ?g/mL Onclarity Self-Collection Kit-Viper LT Onclarity Self-Collection Kit-COR BD Phoenix Automated Microbiology System - Ertapenem GN 0625-8 ?g/mL BD BACTEC 9240, Remanufactured BD BACTEC FX Top BD BACTEC FX Bottom BD BACTEC FX40 Instrument BD BACTEC Digital Thermometer BD BACTEC 9240 BD BBL Nutrient Broth BD BBL Brain Heart Infusion BD BBL Trypticase Soy Agar Slants BD Phoenix AP ID Broth BD Phoenix Inoculum Broth BD BBL Trypticase Soy Agar (Blood Agar Base), Deeps BD BBL Enriched Thioglycollate Medium BD BBL Trypticase Soy Agar with 5% Sheep Blood and MacConkey II Agar I Plate BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) BD BBL Todd Hewitt Broth BD BBL Trypticase Soy Broth with 20% Glycerol BD Phoenix ID Broth BD BBL Trypticase Soy Broth with 6.5% Sodium Chloride BD BBL Fluid Thioglycollate Medium, Enriched BD BBL Trypticase Soy Broth BD BBL Blood Agar Slants BD BBL Trypticase Soy Agar (Soybean-Casein Digest Agar) BD BBL Todd Hewitt Broth with Gentamicin and Nalidixic Acid BD BBL Thioglycollate Medium with Calcium Carbonate Marble Chip BD BBL Thioglycollate Medium without Indicator - 135C BD BBL Middlebrook 7H9 Broth with Glycerol BD BBL Fluid Thioglycollate Medium BD BBL CDC Anaerobe 5% Sheep Blood Agar BD BBL Brain Heart Infusion Agar Slant BD BBL Schaedler Broth with Vitamin K1 BD BBL Nutrient Agar Slants BD BBL Mueller Hinton Broth BD BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) // Levine EMB Agar BD BBL Sensi-Disc Ticarcillin/Clavulanic Acid 75/10 ?g BD Phoenix Automated Microbiology System - Ceftaroline GN 0156-4 ?g/mL BD BACTEC Lytic/10 Anaerobic/F Culture Vials BD Phoenix Automated Microbiology System - Tigecycline GN 0.25-16 ?g/mL BD PhoenixSpec AP Calibrator Kit BD PhoenixSpec Nephelometer BD PhoenixSpec Calibrator 2 McFarland BD Phoenix AP BD Kiestra ID AST Calibrator Kit BD PhoenixSpec Calibrator Kit BD PhoenixSpec Calibrator 0.25 McFarland BD PhoenixSpec Calibrator 0.50 McFarland BD Difco Listeria O Antiserum Type 4 BD Difco Listeria O Antiserum Type 1 BD Difco Listeria O Antiserum Poly Serotypes 1, 4 BD Phoenix Automated Microbiology System - Cefoxitin GP 1-32 ?g/mL BD BBL Sensi-Disc Ceftazidime 30 ?g BD Phoenix Automated Microbiology System - Ampicillin/Sulbactam GN 0.5/0.25-32/16 ?g/mL BD Phoenix Automated Microbiology System - Moxifloxacin Strep 0625-8 ?g/mL BD Phoenix Automated Microbiology System - Ceftriaxone GN 0.5-64 ?g/mL BD Phoenix Automated Microbiology System - Cefepime GN 0.5-64 ?g/mL BD BBL Sensi-Disc Cefmetazole 30 ?g BD Phoenix Automated Microbiology System - Ampicillin GN 0.5-32 ?g/mL BD Viper System BD Viper System Remanufactured BD Viper Neutralization Pouch BD Phoenix Automated Microbiology System - Cefazolin GN 0.5-32 ?g/mL BD Phoenix Automated Microbiology System - CPO Detect BD Phoenix Automated Microbiology System - Meropenem/vaborbactam GN 0.125/8-32/8 ?g/mL BD Kiestra InoqulA Magnetic Beads BD Kiestra Isolate Suspension Cuvette Array BD BBL Sensi-Disc Cefotaxime 30 ?g BD BBL Sensi-Disc Imipenem 10 ?g BD Intramedic Luer-Stub Adapter BD Phoenix Automated Microbiology System - Nitrofurantoin GP 4-128 ?g/mL BD BACTEC Standard Anaerobic/F Culture Vials BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Molecular Swab Collection Kit BD Molecular LBC Sample Buffer Tubes BD Molecular Swab Sample Buffer Tubes BD Molecular Urine Transport Kit BD MAX CTGCTV2 BD MAX System BD MAX Enteric Parasite Panel BD Pre-Warm Heater BD MAX System BD Veritor Plus Analyzer BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution BD Phoenix Automated Microbiology System - Minocycline GP 1-32mg/mL BD BACTEC MGIT 960 PZA Medium BD BACTEC MGIT 960 PZA Kit BD Phoenix Automated Microbiology System - Cefoxitin GN 0.5-64 ?g/mL BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD MAX Vaginal Panel BD MAX System BD Molecular Swab Collection Kit BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Phoenix Automated Microbiology System - Ciprofloxacin GN 0156-4?g/mL BD Veritor System For Rapid Detection of RSV - CLIA waived kit BD BBL Mueller Hinton Agar with 5% Sheep Blood BD Macro-Vue RPR Card Test Liquid Controls BD Phoenix Automated Microbiology System - Gentamicin GP 0.25-16 ?g/mL BD BBL Streptocard Acid Test Latex A BD BBL Streptocard Enzyme Test Latex B BD BBL Streptocard Enzyme Test Latex D BD BBL Streptocard Acid Test Latex F BD BBL Streptocard Acid Test Latex G BD BBL Streptocard Acid Extraction Reagent BD BBL Streptocard Acid Test Latex D BD BBL Streptocard Acid Positive Control BD BBL Streptocard Enzyme Latex Test Kit BD BBL Streptocard Acid Latex Test Kit BD BBL Streptocard Acid Test Latex C BD BBL Streptocard Enzyme Extraction BD BBL Streptocard Enzyme Test Latex A BD BBL Streptocard Enzyme Positive Control BD BBL Streptocard Acid Test Latex B BD BBL Streptocard Test Cards BD BBL CHROMagar Candida BD BBL Bile Esculin Agar Slants BD BBL Sabouraud Dextrose Agar (Deep Fill) BD BBL Pseudosel Agar (Cetrimide Agar) BD BBL Mannitol Salt Agar BD BBL Sabouraud Dextrose Agar Slants BD BBL Sabouraud Dextrose Agar with Chloramphenicol Slants BD BBL Enterococcosel Broth BD BBL MacConkey II Agar BD BBL CHROMagar Staph aureus BD BBL Dermatophyte Test Medium, Modified with Chloramphenicol BD BBL Salmonella Shigella Agar BD BBL Levine EMB Agar BD BBL CHROMAgar Salmonella BD BBL Hektoen Enteric Agar BD BBL MacConkey II Agar with Sorbitol BD BBL Group A Selective Strep Agar w/5% Sheep Blood (ssA) Liquid Based Cytology (LBC) Dilution Tubes for the BD ProbeTec Qx Amplified DNA Assays BD Veritor System Group A Strep Control Swab set BD Veritor System RSV Control Swab Set BD Veritor System Flu A+B Control Swab Set BD Veritor SARS-CoV-2 Control Swab Set BD BBL CHROMagar O157 BD Phoenix Automated Microbiology System - Confirmatory ESBL Test BD Difco Salmonella H Antiserum Single Factor z15 BD Difco Salmonella H Antiserum Z4 Complex BD Difco Salmonella H Antiserum Single Factor m BD Difco Salmonella H Antiserum Single Factor 5 BD Difco Salmonella H Antiserum Single Factor 6 BD Difco Salmonella H Antiserum Poly D Contains z35, z36, z37, z38, z39, z41, z42 BD Difco Salmonella O Antiserum Poly AI & Vi BD Difco Salmonella O Antiserum Group C3 Factors (8), 20 BD Difco Salmonella O Antiserum Group A Factors 1, 2, 12 BD Difco Salmonella O Antiserum Factor 12 BD Difco Salmonella H Antiserum z29 BD Difco Salmonella O Antiserum Factor 34 BD Difco Salmonella O Antiserum Poly F Groups 51, 52, 53, 54, 55 BD Difco Salmonella O Antiserum Group G1 Factors 13, 22, (36) BD Difco Salmonella H Antiserum Single Factor x BD Difco Salmonella H Antiserum d BD Difco Salmonella O Antiserum Poly D Groups P, Q, R, S, T, U BD Difco Salmonella H Antiserum Single Factor f BD Difco Salmonella O Antiserum Poly E Groups V, W, X, Y, Z BD Difco Salmonella H Antiserum Single Factor w BD Difco Salmonella H Antiserum L Complex BD Difco Salmonella O Antiserum Factor 5 BD Difco Salmonella O Antiserum Group E1 Factors 3, 10 BD Difco Salmonella O Antiserum Factor 8 BD Difco Salmonella H Antiserum Single Factor 7 BD Difco Salmonella H Antiserum z6 BD Difco Salmonella O Antiserum Poly B Groups C1, C2, F, G, H BD Difco Salmonella H Antiserum Poly A Contains a, b, d, i, z10, z29 BD Difco Salmonella Vi Antiserum BD Difco Salmonella H Antiserum Poly a-z BD Difco Salmonella H Antiserum Single Factor s BD Difco Salmonella H Antiserum Single Factor p BD Difco Salmonella H Antiserum z10 BD Difco Salmonella H Antiserum eh BD Difco Salmonella O Antiserum Group D2 Factors (9), 46 BD Difco Salmonella H Antiserum Single Factor 2 BD Difco Salmonella H Antiserum r BD Difco Salmonella O Antiserum Group B Factors 1, 4, 5, 12 BD Difco Salmonella O Antiserum Factor 22 BD Difco Salmonella O Antiserum Factor 7 BD Difco Salmonella O Antiserum Group F Factor 11 BD Difco Salmonella H Antiserum k BD Difco Salmonella O Antiserum Factor 15 BD Difco Salmonella H Antiserum b BD Difco Salmonella O Antiserum Group E Factors 1, 3, 10, 15, 19, 34 BD Difco Salmonella O Antiserum Factors 4, 5 BD Difco Salmonella H Antiserum Single Factor h BD Difco Salmonella H Antiserum Spicer-Edwards 3 BD Difco Salmonella H Antiserum Spicer-Edwards 2 BD Difco Salmonella H Antiserum Poly E Contains z6, 1 complex BD Difco Salmonella O Antiserum Factor 2 BD Difco Salmonella O Antiserum Poly C Groups I, J, K, M, N, O BD Difco Salmonella O Antiserum Factor 20 BD Difco Salmonella O Antiserum Group C2 Factors 6, 8 BD Difco Salmonella H Antiserum 1 Complex BD Difco Salmonella H Antiserum z BD Difco Salmonella H Antiserum Spicer-Edwards 1 BD Difco Salmonella H Antiserum y BD Difco Salmonella O Antiserum Factor 9 BD Difco Salmonella O Antiserum Group J Factor 17 BD Difco Salmonella O Antiserum Group E4 Factors 1, 3, 19 BD Difco Salmonella H Antiserum EN Complex BD Difco Salmonella H Antiserum Single Factor t BD Difco Salmonella H Antiserum G Complex BD Difco Salmonella O Antiserum Group H Factors 1, 6, 14, 24, 25 BD Difco Salmonella H Antiserum c BD Difco Salmonella O Antiserum Factor 19 Identifying Factor for Group E4 BD Difco Salmonella O Antiserum Group G Factors 13, 22, 23, (36), (37) BD Difco Salmonella O Antiserum Group E3 Factors (3), (15), 34 BD Difco Salmonella O Antiserum Group B Factors 1, 4, 12, 27 BD Difco Salmonella H Antiserum Spicer-Edwards 4 BD Difco Salmonella O Antiserum Poly G Groups 56, 57, 58, 59, 60, 61 BD Difco Salmonella O Antiserum Factor 23 BD Difco Salmonella O Antiserum Factor 4 BD Difco Salmonella H Antiserum Poly B Contains eh, en, enx, enz15, G complex BD Difco Salmonella H Antiserum a BD Difco Salmonella H Antiserum i BD Difco Salmonella O Antiserum Group D1 Factors 1, 9, 12 BD Difco Salmonella O Antiserum Factor 10 Identifying Factor for Group E1 BD Difco Salmonella O Antiserum Poly A Groups A, B, D, E1, E2, E3, E4, L BD Difco Salmonella O Antiserum Group I Factor 16 BD Difco Salmonella O Antiserum Factor 14 BD Difco Salmonella H Antiserum Poly C Contains k, r, y, z, z4, L complex BD Difco Salmonella O Antiserum Group C1 Factors 6, 7 BD BBL Sensi-Disc Metronidazole 80 µg BD Macro-Vue RPR Card Test Control Card BD Phoenix Automated Microbiology System - Cefepime GN 0.5-64 ?g/mL BD BBL Sensi-Disc Clarithromycin 15 ?g BD Phoenix Automated Microbiology System - Aztreonam GN 0.5-64 ?g/mL BD Phoenix Automated Microbiology System - Meropenem GN 0.125-32 ?g/mL BD Phoenix Automated Microbiology System - Cefepime Strep 0625-4 ?g/mL BD BBL Sensi-Disc Ticarcillin 75 ?g BD BBL Sensi-Disc Amoxicillin/Clavulanic Acid 20/10 ?g BD BBL Sensi-Disc Piperacillin/Tazobactam 100/10 ?g BD Phoenix Automated Microbiology System - Eravacycline GN 0.125-2 ?g/mL BD Phoenix Automated Microbiology System - Levofloxacin Strep 0.25-16 ?g/mL BD Phoenix Automated Microbiology System - Tetracycline GP 0.5-16 ?g/mL BD Phoenix Automated Microbiology System - Tetracycline GN 0.5-16 ?g/mL BD Phoenix Automated Microbiology System - Nalidixic Acid GN 2-32 ?g/mL BD Phoenix Automated Microbiology System - Ampicillin GN 0.5-32 ?g/mL BD BBL TB Auramine M BD BBL TB Auramine-Rhodamine T BD BBL Sensi-Disc Ceftriaxone 30 ?g BD Phoenix Automated Microbiology System - Cefazolin GP 2-32 ?g/mL BD BBL Mueller Hinton II Broth, Cation-Adjusted BD Difco Mueller Hinton Broth BD MAX Cdiff BD MAX System BD Phoenix Automated Microbiology System - Ceftolozane/tazobactam GN 0.25/4-32/4 ?g/mL BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD MAX Extended Enteric Bacterial Panel BD MAX System BD BBL Sensi-Disc Moxifloxacin 5 ?g BD BACTEC Plus Aerobic/F Culture Vials BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD BBL Sensi-Disc Ampicillin/Sulbactam 10/10 µg BD Phoenix Automated Microbiology System - Ampicillin GP 0625-32 ?g/mL BD Macro-Vue RPR Card Test BD Phoenix NID BD BBL Venting Unit BD BACTEC Subculturing/Aerobic Venting Unit BD Phoenix Automated Microbiology System - Trimethoprim/Sulfamethoxazole GP 0.5/9.5-16/304 ?g/mL BD GasPak EZ Campy Gas Generating Pouch System BD BBL Dry Anaerobic Indicator Strips BD GasPak EZ Campy Container System Sachets BD Bio-Bag Type C BD GasPak EZ Anaerobe Gas Generating Pouch System with Indicator BD GasPak EZ Anaerobe Container System Sachets with Indicator BD GasPak EZ Small Incubation Container BD GasPak EZ Large Incubation Container BD GasPak EZ Anaerobe Container System Sachets BD GasPak EZ Standard Incubation Container BD BBL CO2 Indicators BD CO2 Gas Generators BD GasPak EZ CO2 Gas Generating Pouch System BD GasPak EZ CO2 Container System Sachets BD Phoenix Automated Microbiology System - Linezolid Strep 0.25-16 ?g/mL BD Phoenix Automated Microbiology System - Penicillin Strep 0156-32 ?g/mL BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack BD Phoenix Automated Microbiology System - Tigecycline GP 0313-4 ?g/mL BD Phoenix Automated Microbiology System - Piperacillin GN 0.5-128 ?g/mL BD BACTEC Myco/F Lytic Culture Vials BD Phoenix NMIC Panels BD Phoenix SMIC Panels BD Phoenix PMIC/ID Panels BD Phoenix NMIC/ID Panels BD Phoenix SMIC/ID Panels BD Phoenix PMIC Panels BD BACTEC FOS Culture Supplement Kit BD Phoenix Automated Microbiology System - Cefuroxime GN 1-64 ?g/mL BD Phoenix Automated Microbiology System - Meropenem GP 0.5-16 ?g/mL BD BBL Sensi-Disc Minocycline 30 ?g BD BACTEC Lytic/10 Anaerobic/F Culture Vials BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD MAX Enteric Bacterial Panel BD MAX System BD MAX MRSA XT BD MAX System BD Phoenix Automated Microbiology System - Cefepime GN 0.5-64 ?g/mL BD Difco Vibrio cholerae Antiserum Ogawa BD Difco Vibrio cholerae Antiserum Inaba BD Difco Vibrio cholerae Antiserum Poly Hikojima, Inaba, Ogawa BD BBL Sensi-Disc Cefaclor 30 ?g BD MAX Enteric Viral Panel BD MAX System BD Phoenix Automated Microbiology System - Piperacillin/Tazobactam GN 0.5/4-128/4 ?g/mL BD Phoenix Automated Microbiology System - Ceftriaxone Strep 0625-4 ?g/mL BD BBL TB Carbolfuchsin ZN BD BBL TB Carbolfuchsin KF BD Phoenix Automated Microbiology System - Vancomycin Strep 0625-32 ?g/mL BD Phoenix AST-S Broth BD Phoenix AST-S Indicator Solution BD Phoenix Automated Microbiology System - Cefuroxime GN 1-64 ?g/mL BD BACTEC FXI Culture System Analyzer Module BD BACTEC FXI Culture System Workflow Module BD BACTEC FXI 480/960 Culture System Software BD BBL Staphyloslide Latex Test Kit BD Phoenix Automated Microbiology System - Linezolid GP 0.25-32 ?g/mL BD Phoenix Automated Microbiology System - Erythromycin GP 0625-8 ?g/mL BD Phoenix Automated Microbiology System - Levofloxacin GN 0.25-8 ?g/mL BD Phoenix Automated Microbiology System - Levofloxacin GP 0.25-8 ?g/mL BD BACTEC 9120, Remanufactured BD BACTEC 9120 BD Phoenix Automated Microbiology System - Ceftazidime GN 0.5-64 ?g/mL BD Phoenix Automated Microbiology System - Cephalothin GN 1-64 ?g/mL BD BBL Sensi-Disc Meropenem 10 ?g BD Phoenix Automated Microbiology System - Cefotaxime Strep 0625-4 ?g/mL BD Difco Bordetella pertussis Antigen BD BACTEC MGIT 960 IR Kit BD BACTEC MGIT 960 SIRE Kit BD BBL Thioglycollate Medium without Indicator BD Difco Supplement C BD Difco Nitrate Broth BD BBL Casman Agar Base BD BBL SIM Medium BD BBL CLED Agar BD BBL Phytone Yeast Extract Agar BD BBL Trichosel Broth, Modified BD BBL Enterococcosel Agar BD Difco Tryptic Soy Broth without Dextrose BD BBL Hemoglobin Solution 2% BD Difco Egg Yolk Enrichment 50% BD BBL Middlebrook ADC Enrichment BD Difco Fluid Thioglycollate Medium with Beef Extract BD Difco CHROMagar Salmonella BD Difco MacConkey Sorbitol Agar BD Difco Urea Broth BD Difco Lactose BD Difco MacConkey Agar without Salt BD BBL Cary-Blair Transport Medium BD Difco Antimicrobic Vial K BD BBL Kligler Iron Agar BD Difco Decarboxylase Medium Base BD BBL Eosin Methylene Blue Agar, Levine BD Difco Pseudomonas Isolation Agar BD Difco Heart Infusion Agar BD Difco Yersinia Selective Agar Base BD BBL MacConkey Agar without Crystal Violet BD Difco Oxgall (Dehydrated Fresh Bile) BD Difco Cetrimide Agar Base BD Difco Dextrose BD Difco Soluble Starch BD BBL Fluid Thioglycollate Medium BD Difco Phenol Red Mannitol Agar BD BBL Moeller Decarboxylase Broth Base BD BBL Transport Medium BD BBL Urea Agar Base BD Difco Saccharose BD Difco Koser Citrate Medium BD Difco MIL Medium BD Difco Hektoen Enteric Agar BD Difco SS Agar BD Difco Beef Heart BD Difco OF Basal Medium BD ZeroFoam BD Horizon Brilliant Stain Buffer BD Detergent Solution Concentrate BD Extended Flow Cell Clean Solution BD Alcohol Blend Rinse BD MAX DNA MMK (SPC) BD FACSFlow Sheath Fluid BD BBL Schaedler Agar BD FACSRinse Solution BD Sheath Additive BD Disinfectant-nCL BD BBL Bovine Albumin (Fraction V) BD Difco Agar BD Difco Brain Heart Infusion Agar BD Stabilizing Fixative BD BBL Saline, Normal BD BBL Mannitol Salt Agar BD Difco Tryptic Soy Blood Agar Base No. 2 BD Difco Yeast Carbon Base BD Difco Cooked Meat Medium BD Difco MacConkey Broth BD Difco Candida BCG Agar Base BD Difco Pseudomonas Agar F BD BBL Phosphate Buffer, pH 7.2 BD BBL V-C-N Inhibitor BD BBL Mycosel Agar BD Difco MacConkey Agar Base BD FACS Sheath Solution with Surfactant BD Difco Lysine Iron Agar BD Difco Leptospira Medium Base EMJH BD BBL Phenol Red Broth Base BD Difco Potato Dextrose Broth BD BBL V-C-N-T Inhibitor BD Difco Sabouraud Brain Heart Infusion Agar Base BD BBL Brucella Broth BD Difco Veal Infusion Broth BD BBL Brucella Agar BD Difco Salicin BD Difco D-Sorbitol BD Difco Todd Hewitt Broth BD Difco Azide Blood Agar Base BD Difco Tinsdale Agar Base BD Difco Potato Dextrose Agar BD BBL Brain Heart Infusion BD Difco Columbia Blood Agar Base BD Difco SBG Sulfa Enrichment BD Difco Fraser Broth Supplement BD Difco Phenylalanine Agar BD Difco Brewer Anaerobic Agar BD Difco Columbia Broth BD BBL Inhibitory Mold Agar BD Difco Antimicrobic Vial A BD Difco Lysine Decarboxylase Broth BD BBL Trypticase Soy Broth BD BBL LBS Agar BD Difco Agar, Technical BD Difco Nutrient Broth BD BBL Seven H11 Agar Base BD Difco Nutrient Agar 1.5% BD BBL Columbia Agar Base BD BBL Dermatophyte Test Medium Base BD Difco D-Galactose BD Difco Nutrient Gelatin BD BBL Trypticase Soy Agar, Modified (TSA II) BD Difco Desoxycholate Agar BD BBL Brain Heart Infusion Broth, Modified BD Difco PPLO Agar BD BBL FTA Hemagglutination Buffer BD Difco Brilliant Green Agar BD Difco Middlebrook 7H9 Broth BD FACSClean Solution BD Difco Eugon Agar BD Difco MIO Medium BD Difco Tween 80 BD BBL Phenol Red Mannitol Broth BD Difco Novobiocin Antimicrobic Supplement BD Difco Asparagine BD BBL Select Agar BD Difco FA Buffer, Dried BD Difco Nutrient Agar BD BBL Enterococcosel Broth BD BBL Indole Nitrite Medium BD BBL Bile Esculin Agar BD BBL Blood Agar Base Infusion Agar BD Difco Agar, Noble BD BBL Corn Meal Agar BD BBL MR-VP Broth 659611_BD Horizon Brilliant Stain Buffer BD BBL Phenol Red Lactose Broth BD Difco Thioglycollate Medium without Indicator BD Difco ISP Medium 4 BD Difco Lowenstein Medium Base BD Difco Selenite Broth BD Difco Bile Salts No. 3 BD Difco Tryptic Soy Agar BD BBL MacConkey Agar BD BBL BiGGY Agar BD Difco Bordet Gengou Agar Base BD Difco Eugon Broth BD Difco Starch Agar BD BBL Trypticase Soy Broth, Sterile BD BBL TSN Agar BD Difco Tryptose Phosphate Broth BD BBL Simmons Citrate Agar BD BBL Motility Test Medium BD FACS Shutdown Solution BD Difco Sabouraud Dextrose Agar BD Difco Sabouraud Agar, Modified BD Difco Tryptose Broth BD Difco Cystine Tryptic Agar BD Difco Brain Heart Infusion BD Difco Gelatin BD BBL Vitamin K1 - Hemin Solution BD Difco D-Mannitol BD MAX DNA MMK BD BBL Egg Yolk Tellurite Enrichment BD Difco Mitis Salivarius Agar BD BBL MycoPrep Kit BD Difco PPLO Broth BD Difco Liver Infusion Broth BD Difco Glycerol BD Difco NIH Thioglycollate Broth BD BBL Phenylethyl Alcohol Agar BD Difco ISP Medium 2 BD Difco Fluid Thioglycollate Medium BD Difco DNase Test Agar BD Difco Tinsdale Enrichment Desiccated BD Difco Anaerobic Agar BD BBL Thioglycollate Medium, Brewer Modified BD MAX TNA MMK(SPC) BD Difco Sodium Desoxycholate BD BBL Trypticase Soy Agar BD Difco Purple Agar Base BD BBL Brain Heart Infusion Agar BD Difco Motility GI Medium BD Difco Tryptose Agar BD BBL GN Broth BD Difco GN Broth, Hajna BD BBL Mycophil Agar with Low pH BD Difco Columbia Agar Base II BD BBL Salmonella Shigella Agar BD Difco Purple Broth Base BD Difco Malonate Broth BD BBL Middlebrook OADC Enrichment BD Difco Leptospira Enrichment EMJH BD Difco Antimicrobic Vial P BD BBL Litmus Milk BD Difco GC Medium Base BD Difco EY Tellurite Enrichment BD Difco Triple Sugar Iron Agar BD Difco Pseudomonas Agar P BD BBL Phenol Red Dextrose Broth BD Difco Yersinia Antimicrobic Supplement CN BD Difco MacConkey Agar BD BBL IsoVitaleX Enrichment BD Difco Desoxycholate Lactose Agar BD Difco TCBS Agar BD Difco Brain Heart Infusion, Porcine BD BBL Mycoplasma Broth Base BD Rhamnose BD Difco Supplement B with Reconstituting Fluid BD Difco Dubos Broth Base BD BBL Agar, Grade A BD Difco Liver Veal Agar BD BBL Hemoglobin, Bovine, Freeze-Dried BD BBL Eosin Methylene Blue Agar, Modified BD BBL Columbia CNA Agar BD Difco Supplement VX with Reconstituting Fluid BD BBL CTA Medium BD BBL MacConkey II Agar BD BBL Mycoplasma Agar Base BD BBL BCYE Agar Base BD Difco Columbia Blood Agar Base EH BD BBL Spirolate Broth BD Difco XLD Agar BD Difco Sabouraud Dextrose Broth BD Difco Legionella Agar Enrichment BD Difco Heart Infusion Broth BD Difco Tryptic Soy Broth BD Difco Skim Milk BD Difco Maltose BD Difco Selenite Cystine Broth BD Difco Mycoplasma Supplement BD Difco Tryptose Blood Agar Base BD Difco Raffinose BD Difco Charcoal Agar BD Difco Agar, Granulated BD Phoenix Automated Microbiology System - Ticarcillin/Clavulanate GN 1/2-128/2 ?g/mL BD Phoenix Automated Microbiology System - Moxifloxacin GP 0.125-8 ?g/mL BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel Diluent for BD COR System Bacterial Panel plus for BD COR System, and Enteric BD Kiestra ReadA Compact BD Kiestra ReadA BD Phoenix M50 Automated Microbiology System BDXpert System BD Difco Neisseria Meningitidis Antiserum Group W135 BD Difco Neisseria Meningitidis Antiserum Group C BD Difco Neisseria Meningitidis Antiserum Group D BD AffirmVPIII Microbial Identification Test BD Phoenix Automated Microbiology System - Ampicillin/Sulbactam GN 1/0.5-32/16 ?g/mL BD BBL Sensi-Disc Cefoperazone 75 ?g BD MAX System BD MAX Vaginal Panel BD Phoenix Automated Microbiology System - Vancomycin GP 0.5-32 ?g/mL BD BACTEC 9050 BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD BACTEC Peds Plus/F Culture Vials BD Phoenix Automated Microbiology System - Ciprofloxacin GN 0.125-4 ?g/mL BD Phoenix Automated Microbiology System - Ceftazidime GN 0.5-64 ?g/mL BD BBL Sensi-Disc Azithromycin 15 ?g BD Phoenix Automated Microbiology System - Amikacin GN 0.5-64 ?g/mL BD Phoenix Automated Microbiology System - Daptomycin GP 0.125-32 ?g/mL BD Macro-Vue RPR Card Antigen Suspension BD Difco Bordetella pertussis Antiserum BD CTGCTV2 BD Phoenix Automated Microbiology System - Moxifloxacin GN 0.125-8 ?g/mL BD BACTEC Platelet Aerobic/F Culture Vials BD BACTEC Platelet Anaerobic/F Culture Vials BD Difco Escherichia coli H Antiserum H7 BD Difco Escherichia coli O Antiserum O157 BD Affirm VPIII Microbial Identification Test BD Onclarity HPV Assay Reagent Pack BD Onclarity HPV Extraction Reagent Trough for BD COR BD Onclarity HPV LBC Diluent Tubes BD FOX PCR Extraction Tubes BD Control set for the BD Onclarity HPV Assay BD Viper LT System PCR Accessory Kit BD COR PX Instrument BD Viper LT System BD Onclarity HPV SurePath Diluent Tubes BD Onclarity HPV Assay Diluent for BD COR BD COR GX Instrument BD Onclarity HPV Self Collection Diluent Tube BD Copan FLOQSwabs for HPV Self Collection BD Viper LT System PCR Tube/Tray Kit BD Viper PCR Extraction Reagent Trough with Piercing Tool BD BBL Sensi-Disc Fosfomycin 200 ?g BD CytoRich Clear Collection Vial BD Microtainer® Tube Extender BD MAX Extended Enteric Bacterial Panel BD MAX Enteric Bacterial Panel BD MAX System BD BBL Sensi-Disc Norfloxacin 10 ?g BD BACTEC MGIT 960 INH 0.4 Kit BD BACTEC MGIT 960 SIRE Kit BD BACTEC MGIT 960 STR 4 Kit BD BACTEC MGIT 960 IR Kit BD Phoenix Automated Microbiology System - Norfloxacin GP 0.25-16 ?g/mL BD Phoenix Automated Microbiology System - Erythromycin GP 0625-8 ?g/mL BD Phoenix Automated Microbiology System - Chloramphenicol GP 1-32 ?g/mL BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD BBL Sensi-Disc Netilmicin 30 µg Liquid Based Cytology (LBC) Dilution Tubes for the BD ProbeTec Qx Amplified DNA Assays BD BBL Acridine Orange Reagent Droppers BD BBL Acridine Orange Stain BD MAX CPO BD MAX System BD Kiestra Slides BD BBL Sensi-Disc 8-Place Self-Tamping Dispenser BD BBL Sensi-Disc 6-Place Self-Tamping Dispenser BD BBL Sensi-Disc 12-Place Self-Tamping Dispenser BD Kiestra IdentifA WCA Connection BD Kiestra IdentifA Manual Infeed BD BBL Sensi-Disc Single Disc Dispenser BD Kiestra IdentifA TLA Connection BD Macro-Vue Card Test Rotator BD Dispenstirs BD Disposable Inoculating Needles, Violet BD Calibrated Disposable Inoculating Loops, Green BD Calibrated Disposable Inoculating Loops, Blue BD Phoenix Automated Microbiology System - Imipenem GN 1-16 ?g/mL BD BBL Modified Thayer-Martin (MTM II) Agar BD Phoenix Automated Microbiology System - Gentamicin GN 0.25-16 ?g/mL BD BBL MGIT OADC Enrichment BD BBL MGIT PANTA Antibiotic Mixture BD BACTEC MGIT 960 BD BACTEC MGIT Mycobacteria Growth Indicator Tubes BD BACTEC MGIT 960 Supplement Kit BD BACTEC MGIT 960 Instrument, Refurbished BD BACTEC MGIT 320 BD BACTEC MGIT II 960 BD BACTEC MGIT 960 Calibration Vial BD BACTEC MGIT II 320 BD BACTEC Peds Plus/F Culture Vials BD MAX StaphSR BD MAX System BD MicroProbe Processor BD Phoenix Automated Microbiology System - Ceftazidime GN 0.5-64 ?g/mL BD Respiratory Viral Panel for BD MAX System BD Respiratory Viral Panel-SCV2 for BD MAX System BD Phoenix Automated Microbiology System - Gatifloxacin GP 0.25-8 ug/mL BD Phoenix Automated Microbiology System - Gatifloxacin GN 0.25-8 ug/mL BD Phoenix AST Broth BD Phoenix M50 Automated Microbiology System BD Phoenix Emerge AST Indicator Solution BD Phoenix Emerge AST Broth BD Phoenix AST Indicator Solution BD Phoenix AST Broth 4.5 mL BD Phoenix AP AST Indicator Solution BD Phoenix Automated Microbiology System - Tetracycline GN 0.5-16 ?g/mL BD Phoenix Automated Microbiology System - Ticarcillin/Clavulanate GN 1/2-128/2 ?g/mL BD Phoenix Automated Microbiology System - Amoxicillin Strep 0313-32 ?g/mL BD MAX Vaginal Panel BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Phoenix Automated Microbiology System - Ciprofloxacin GN 0.25-4 ?g/mL BD Phoenix Automated Microbiology System - Moxifloxacin GP 0.125-8 ?g/mL BD BBL Mueller Hinton II Agar BD Phoenix Automated Microbiology System - Ertapenem GN 0625-8 ?g/mL BD Swab Diluent for BD ProbeTec Qx Amplified DNA Assays Urine Preservative Transport for BD ProbeTec Qx Amplified DNA Assays Control Set for the BD ProbeTec (CT/GC) BD Vaginal Specimen Transport for BD ProbeTec Qx Amplified DNA Assays BD Viper Neutralization Pouch BD Viper Extraction Reagent and Lysis Trough BD FOX Extraction Tubes BD ProbeTec Qx Collection Kit for Endocervical or Lesion Specimens Male Urethral Collection Kit for BD ProbeTec (CT/GC) Qx Amplified DNA Assays BD Veritor System For Rapid Detection of RSV - Laboratory kit BD Phoenix Automated Microbiology System - Meropenem GN 0.25-16 ?g/mL BD MAX ExK TNA-3 BD MAX ExK TNA-2 BD MAX ExK DNA-3 BD MAX ExK DNA-2 BD MAX System BD MAX ExK DNA-1 BD BBL Sensi-Disc Cefuroxime 30 ?g BD Veritor System for Rapid Detection of Group A Strep CLIA-Waived Kit BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD Phoenix Automated Microbiology System - Minocycline GN 1-32mg/mL BD PCR Cartridge BD MAX GBS Assay BD MAX System BD BBL Sensi-Disc Cefixime 5 ?g BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Affirm VPIII Microbial Identification Test BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Phoenix YEAST ID BD Difco QC Antigen Salmonella O Group D BD Difco QC Antigen Salmonella O Group A BD Difco QC Antigen Salmonella Vi BD BBL Sensi-Disc Linezolid 30 ?g BD Vaginal Panel BD COR MX Instrument BD COR PX Instrument BD Phoenix Automated Microbiology System - Trimethoprim/Sulfamethoxazole Strep 0625/1.2-16/304 ?g/mL SURE PREP CAPILLARY TUBES BD SurePrep Capillary Tubes- PRECALIBRATED BD SurePrep Capillary Tubes- HEPARINIZED BD SurePrep Capillary Tubes- PLAIN BD Phoenix Automated Microbiology System - Nitrofurantoin GN 8-512 ?g/mL BD SARS-CoV-2 Reagents for BD MAX System BD BACTEC Myco/F Lytic Culture Vials BD Phoenix Automated Microbiology System - Nitrofurantoin GP 16-512 ?g/mL BD Phoenix Automated Microbiology System - Chloramphenicol GP 1-32 ?g/mL BD Surepath PreCoat Slides BD Totalys SlidePrep Non-GYN Test Kit BD PrepStain Non-GYN Test Kit BD Phoenix Automated Microbiology System - Cefazolin GN 0.5-32 ?g/mL BD Phoenix Automated Microbiology System - Clindamycin GP 0.125-8 ?g/mL BD Phoenix Automated Microbiology System - Rifampin GP 0.25-32 ?g/mL BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD BBL Coagulase Plasma, Rabbit BD BBL Coagulase Plasma, Rabbit with EDTA BD Phoenix Automated Microbiology System - Vancomycin GP 0.5-32 ?g/mL BD Kiestra IdentifA BD BBL TB Brilliant Green K BD BBL Sensi-Disc Cefpodoxime 10 ?g BD Phoenix Automated Microbiology System - Cefotaxime GN 0.5-64 ?g/mL BD Phoenix Automated Microbiology System - Tetracycline GP 0.5-16 ?g/mL BD Phoenix Automated Microbiology System - Aztreonam GN 0.5-64 ?g/mL BD BBL Sensi-Disc Levofloxacin 5 ?g BD Phoenix PID BD MAX Enteric Parasite Panel BD MAX System BD Pre-warm Heater BD BACTEC 9050

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2023-01-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2014-06-09
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-02-06
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2009-12-07
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-09-27
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	Class 1	866.2500	2011-04-21
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2001-08-28
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JSD	Culture Media, Selective Broth	Microbiology	Class 1	866.2360	2008-08-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-08-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
SEP	Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay	Microbiology	Class 2	866.2920	2026-06-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-08-18
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-05-17
JSC	Culture Media, General Nutrient Broth	Microbiology	Class 1	866.2350	2004-12-30
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	1977-12-29
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-08-06
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-05-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2014-03-27
JQX	Nephelometer, For Clinical Use	Clinical Chemistry	Class 1	862.2700	1999-08-24
GSH	Antisera, All Types, Listeria Monocytogenes	Microbiology	Class 1	866.3355	1992-12-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2008-02-28
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2018-12-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2018-03-19
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2005-11-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
JTT	Susceptibility Test Powders, Antimicrobial	Microbiology	Class 2	866.1640	2007-12-05
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2004-12-28
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2009-02-11
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-02-15
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2021-08-16
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2021-08-16
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2021-08-16
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2015-08-26
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2015-08-26
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2018-07-31
KZB	Automated Colony Counter	Microbiology	Class 1	866.2170	2018-02-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
MJA	Susceptibility Test Powders, Antimycobacterial	Microbiology	Class 2	866.1640	2007-12-19
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2023-06-06
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-04-02
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2013-11-25
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2023-09-19
GMP	Antisera, Control For Nontreponemal Tests	Microbiology	Class 2	866.3820	2008-07-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	1991-06-28
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2001-05-18
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2009-11-10
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-12-12
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2007-11-21
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	1992-12-27
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
GMP	Antisera, Control For Nontreponemal Tests	Microbiology	Class 2	866.3820	2007-11-29
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2014-03-27
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2014-03-27
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2014-03-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2014-03-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2014-03-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2025-08-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
KJK	Auramine O	Hematology	Class 1	864.1850	2001-05-18
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2007-11-29
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2013-04-08
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2013-04-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2018-01-15
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2017-06-07
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2012-09-25
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2007-11-30
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2004-11-23
JTA	Monitor, Microbial Growth	Microbiology	Class 1	866.2560	2001-08-28
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2000-09-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2014-06-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2014-12-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2023-04-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2009-01-28
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-05-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2013-05-23
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2018-06-04
PCI	Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2014-05-15
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2014-05-15
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2014-05-15
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2014-01-14
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2014-01-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
GSQ	Antiserum, Vibrio Cholerae, All Varieties	Microbiology	Class 2	866.3930	1992-12-27
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2018-12-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2018-12-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	2001-05-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2026-05-29
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Microbiology	Class 1	866.3700	2015-09-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-05-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
GOX	Antigen, B. Pertussis	Microbiology	Class 1	866.3065	1992-12-27
MJA	Susceptibility Test Powders, Antimycobacterial	Microbiology	Class 2	866.1640	2007-12-19
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2007-04-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2025-12-03
PCI	Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2025-12-03
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-12-03
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2004-11-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2025-03-14
GTJ	Antisera, All Groups, N. Meningitidis	Microbiology	Class 2	866.3390	2007-11-28
MLA	Dna Probe, Yeast	Microbiology	Class 1	866.2660	2008-07-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2016-11-04
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2016-11-04
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2016-11-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-11-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-05-17
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2018-03-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2007-11-30
GOY	Antisera, Agglutinating, B. Pertussis, All	Microbiology	Class 1	866.3065	1992-12-27
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2025-08-12
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2025-08-12
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2025-08-12
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2025-08-12
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-08-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2023-09-19
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	1992-12-27
MJK	Dna Probe, Trichomonas Vaginalis	Microbiology	Class 1	866.2660	1996-02-13
MAQ	Kit, Dna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2018-02-19
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2017-03-16
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-01-19
PCI	Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2023-01-19
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2023-01-19
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
MJA	Susceptibility Test Powders, Antimycobacterial	Microbiology	Class 2	866.1640	2007-12-19
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2009-11-10
IDC	Acridine Orange	Hematology	Class 1	864.1850	2005-06-30
POC	System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen	Microbiology	Class 2	866.1640	2019-10-31
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-10-31
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2004-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	Microbiology	Class 2	866.2410	2007-11-29
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-11-29
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2016-03-03
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2013-11-29
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2013-11-29
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2008-03-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2023-08-01
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2023-08-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2023-06-06
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2007-11-29
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-09-19
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2009-01-27
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2012-09-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2004-12-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2013-02-26
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2012-02-22
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2012-02-22
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
MJM	Dna Probe, Gardnerella Vaginalis	Microbiology	Class 1	866.2660	1996-02-13
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2012-07-23
JXB	Kit, Identification, Yeast	Microbiology	Class 1	866.2660	1994-07-14
GRL	Antigens, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	1992-12-27
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2023-04-11
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2023-04-11
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2023-04-11
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-04-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2007-02-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2025-12-01
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2014-07-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2006-03-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2012-09-20
JTL	Plasma, Coagulase, Human, Horse And Rabbit	Microbiology	Class 1	866.2160	1992-12-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-08-18
QQV	Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry	Microbiology	Class 2	866.3378	2023-09-01
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3378	2023-09-01
KJO	Brilliant Green	Hematology	Class 1	864.1850	2001-05-18
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
LQL	Gram Positive Identification Panel	Microbiology	Class 1	866.2660	2004-11-23
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-01-19
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2023-01-19
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-05-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Becton Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002664	Hardy Diagnostics	HARDYDISK LEVOFLOXACIN, 5MCG	2000-10-26
K033458	Becton, Dickinson & CO	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST	2004-05-28
K112000	bioMerieux, Inc.	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26
K790620	Anaerobe Systems	LOMBARD DOWELL BROTH MEDIUMW/TH REONINE	1979-04-23
K811056	Acumedia Manufacturers, Inc.	BRAIN HEART INFUSION	1981-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-05	Becton Dickinson & Co.	1	Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Z-0028-2014	Becton Dickinson & Co. BD Diagnostic Systems	1	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

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8020667	MAST GROUP LTD.	BOOTLE, MERSEYSIDE Liverpool, GB
2022807	HARDY DIAGNOSTICS	Orcutt, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1119779. Last updated year: 2026. Please use registration number 1119779 when referencing this establishment in official correspondence.