REMEL, INC.

FDA Device Registration & Listing · LENEXA, KS, US · Registration 1924669

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1924669
FEI Number
1924669
Entity Name
REMEL, INC.
City/State/Country
LENEXA, KS, US
Establishment Address
12076 Santa Fe Trail Dr, LENEXA, KS 66215, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Thermo Fisher Scientific (Owner Number: 2517925)
Owner / Operator Contact Address
168 Third Avenue, --, Waltham, MA 02451, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

R01621 MH Agar w/2% NaCl Mueller Hinton with 2% NaCl Giemsa Stain Three Step Stain Solution A Modified Wright- Giemsa Stainpack R246403 Giemsa Plus Stain Kit Three Step Stain Set Kwik-Diff Reagent 1, Fixative Buffered Wright-Giemsa Three Step Stain Solution B Kwik-Diff Reagent 3, Methylene Blue Three Step Stain Fixative Kwik-Diff Reagent 2, Eosin Wright-Giemsa Stain Shandon Wright-Giemsa Solution Kwik-Diff Stain Kit Urea-PDA Disk R20389 Selective Rapid Urea Selective Rapid Urea Indoxyl Acetate Disk The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam R064856 Rapid Trehalose Assim Broth R21524 BactiDrop Potassium Hydroxide(KOH) Nitrate Swab R21536 BactiDrop Nitrate A R01693 Potato Dextrose Agar,pH 5.6 R01922 TSA R064730 Thio Med w/Dex,Hem,Vit K R07084 Cooked Meat Med w/Gluc,Hem,Vit K R10150 Sab Dex Agar,Emmons R01605 Middlebrook 7H11 Agar R061032 HI Broth R064422 Sab Dex Agar,Emmons R09062 BHI Supplemented Agar R09746 Sab Dex Agar,pH 5.6 R02055 Chocolate/Chocolate Biplate R01130 BHI Agar R01354 Cornmeal Agar w/PS80 R061010 HI Agar R061136 HI Broth w/BCP,1% Trehalose R062754 Purple Broth Base Ctrl w/DT R08722 Sab Dex Agar,Emmons R01780 Sab Dex,Emmons w/Yst Ext R01132 BHI Agar R01603 Middlebrook 7H11 Agar R061030 HI Broth R064420 Sab Dex Agar,Emmons R08934 TSA R09744 Sab Dex,pH 5.6 R01991 Yeast Malt Extract Agar R05145 Chopped Meat Glucose Broth R061088 HI Broth w/BCP,1% Inositol R07810 Sab Dex Agar pH 5.6 R04080 TSA R07178 Thio Med w/o Ind,w/Dex R20360 PPLO Broth R01296 Charcoal Bld (Regan Lowe) w/o Ceph R060488 Chocolate Agar R061481 MH Broth R08622 Nutrient Agar R05027 PRAS BHI Broth R09558 Middlebrook 7H9 Broth w/PS80 R060270 BHI Broth R07182 Thio Med w/Dex,Hem,Vit K R08262 Cooked Meat Med w/Gluc,Hem,Vit K R01327 Cornmeal w/1% Dextrose R01761 Sab Dex Emmons Agar R064880 TSB R09642 Plate Count Agar,Std Method R08060 BHI Agar R01070 Anaer Reducible NAV R01330 Cornmeal Agar w/PS80,Trypan Blue R060264 BHI Broth R060856 Dubos Polysorbate Albumin Broth R061121 HI Broth w/BCP,1% Ribose R062502 Phenol Red Agar Base Control R08720 Sab Dex Agar,Emmons R01752 SABHI Agar w/Sheep Blood R01685 Plate Count Agar,Std Method R01921 TSA R064720 Thio Med w/Dex,Hem,Vit K R07030 CHO Medium Base Control R10101 LJ Medium R05138 TPGY Broth R01308 Chocolate Agar w/Yst Ext,Hem,Vit K R01702 Potato Flake Agar R061580 Nutrient Broth R064860 TSA R09627 Nutrient Agar (22ml deep) 100/PK R07322 Wilkins Chalgren Broth R01042 Anaer KV Blood Agar R060232 BHI Agar R060572 CTA Base Control R061108 HI Broth w/BCP,1% Mannose R08058 BHI Agar w/Gent R08691 SABHI Agar w/Chlor R01064 Anaer Reducible CNA Bld Agar R01302 Chocolate Agar R060544 Cooked Meat Med w/Gluc,Hem,Vit K R061570 Nutrient Agar R064802 Todd Hewitt Broth R08652 Potato Dextrose Agar R060252 BHI Broth,filtered R060735 Decarboxylase Broth Base R09622 Page Amoeba Saline R061902 OF Medium Base Control R061112 HI Broth w/BCP,1% Melibiose R08066 BHI Agar w/SB R08692 SABHI Agar R01749 SABHI Agar R01303 Chocolate Agar R01697 Potato Dextrose Agar,pH 3.5 R060546 Cooked Meat Med w/Gluc,Hem,Vit K R061572 Nutrient Agar R01036 Anaer Blood Agar R060102 Andrades Broth Base Control R061104 HI Broth w/BCP,1% Mannitol R064805 Todd Hewitt Broth R09626 Nutrient Agar R061903 OF King Medium Base Control R08052 ATS Medium R08690 SABHI Agar R01158 BHI Supplemented Agar R01068 Anaer Reducible LKV Blood Agar R060322 Brucella Broth R061347 Middlebrook 7H9 w/Glyc R08562 Middlebrook 7H10 Agar R060258 BHI Broth R060854 Dubos Polysorbate Albumin Broth R061120 HI Broth w/BCP,1% Rhamnose R05031 PRAS Chopped Meat Broth R060290 BHI Broth w/X&V Factors R062148 Peptone Yeast Glucose Broth R08132 BHI Broth R061344 Middlebrook 7H9 Broth w/Glyc R08696 SABHI Agar w/Sheep Blood R01750 SABHI Agar R07222 TSB R08502 LJ Medium R05030 PRAS Chop Meat RS R060280 BHI Broth w/Fildes R07210 TSA R08500 LJ Medium R01300 Chocolate Agar R060540 Cooked Meat Med w/Hem,Vit K R061483 MH Broth R08650 Potato Dextrose Agar R09620 NonNutrient Agar R060382 Carbon Assim Broth Base Control R01763 Sab Dex Agar,Emmons R064890 TSB R09654 Potato Dextrose Agar R01240 Bordet Gengou Agar R01627 MH Agar w/1% Hgb,1% GCHI R08062 BHI Agar R061064 HI Broth w/BCP,1% Cellobiose R060482 Chocolate Agar R061428 MRS Broth (2ml) 20/PK R064482 Schaedler Broth R08570 Middlebrook 7H11 Agar R065302 Yeast Ferm Broth w/BTB Base Ctrl R09192 Bordet Gengou Agar R09944 TGE Agar R01800 Schaedler Agar w/Blood,Hem,Vit K R02110 Middlebrook 7H11/Middlebrook 7H11 R09516 LJ w/o RNA R05045 PRAS Chopped Meat Carb R065025 TSB w/15% Glycerol R01640 Nutrient Agar R07324 Wilkins Chalgren Agar,2X R01920 TSA R061072 HI Broth w/BCP,1% Dulcitol R064690 Fluid Thio Med R07019 BHI Broth w/Hemin,Vit K R09984 Yeast Carbon Agar R05066 LD Base Medium R01131 BHI Agar R01565 Malt Extract Agar R061012 HI Agar R061202 Jordans Tartrate Agar R062756 Purple Broth Base Ctrl w/DT R08846 Fluid Thio Med R09738 Sab Dex Broth,2% R01910 Tomato Juice Agar R01917 TSA R05140 Chopped Meat Broth R061084 HI Broth w/BCP,1% Glycerol R07664 Fastidious Broth R05025 PRAS BHI Broth R07180 Thio Med w/Dex,Hem,Vit K R08134 BHI Broth w/0.1% Agar R01486 HI Agar R01695 Potato Dextrose Agar,pH 5.6 R04059 MH Agar w/1% Hgb,1% GCHI R07086 Cooked Meat Med w/Gluc,Hem,Vit K R10266 Potato Flake Agar (Bactiflask) R01136 BHI Agar w/SB R05033 PRAS Chopped Meat Agar R060320 Brucella Broth R061346 Middlebrook 7H9 Broth w/Glyc R08556 Middlebrook 7H9 w/PS80 R01801 Schaedler Agar w/Blood,Hem,Vit K R05054 PRAS Cooked Meat Glucose R061080 HI Broth w/BCP,1% Galactose R065029 TSB w/20% Glycerol R07598 BHI Broth w/Horse Serum,Yst Ext R01768 Sab Dex Agar,pH 5.6 R05035 PRAS Chopped Meat Broth R01326 Cornmeal Agar R065002 TSB R01760 Sab Dex Agar,Emmons R061582 Nutrient Broth R07266 Tryptose Agar R064862 TSA R09640 Plate Count Agar,Std Method R08007 Agar 1.5% R01766 Sab Dex Agar,pH 5.6 R065000 TSB R07224 TSB R09656 Potato Dextrose Agar CM0001B NUTRIENT BROTH, CM0001R NUTRIENT BROTH, CM0003B NUTRIENT AGAR, Multiple R01688 Porphyrin Test Agar Bacticard Neisseria R2450030 Xpect Giardia Control R2450020 Xpect Giardia Xpect Giardia Xpect Giardia Control R03343 Haemophilus ID II Triplate (IWP) R21526 BactiDrop Lactophenol Aniline Blue BactiDrop Lactophenol Aniline Blue Xpect Flu A&B Control Vancomycin Disk Multiple Multiple Accessories 95% Dehydrant Isopropanol R40132 Ethanol (95%) 70% Dehydrant R40106 TB Decolorizer (Acid Alcohol) 3% R2470110 Ethanol (70%) Methanol Flex 95 Cell Wash Solution I/NaOH-D 60% Dehydrant CleanCell M 2x2L, Para-Release Spray Isopropyl Alcohol Flex 100 100% Dehydrant R40206 TB Decolorizer (3%) R40134 Acid Ethanol (90%), Methyl Alcohol Flex 80 Acetone Base Mold Release Syntri Safeguard, Flex 100 Fast Flex Kit 1 Ethyl Alcohol 80% Dehydrant Cell Wash Solution I/NaOH-D 2x1, 8L Syntri Safeguard, Isopropyl Alcohol Fast Flex Kit 2 Reagent Alcohol Syntri Safeguard, Dehydrant 100% Clean Cell M 2x2L HE600 Cleaning Kit R21215 Esculin Hydrolysis Reagent R21251 Potassium Hydroxide (KOH) 3% R21221 Hippurate Hydrolysis Reagent R21227 Indole Reagent,Kovac's R21213 Indole Reagent,Ehrlich's R21258 PYR Reagent R21281 VP-B (40% KOH) BTL/25ml R21254 Potassium Tellurite (0.2%) R21231 Potassium Hydroxide (KOH) 20% R21230 Potassium Hydroxide (KOH) 10% R21200 VP-A (alpha napthol 5%) R211347 E. coli Screen w/Kovacs R21239 Nitrate Reagent A R21206 Bile Solubility Reagent (10%) R21245 Spot Indole Reagent (DMACA) R21226 Gelatin Reagent (12.5%) R21218 Ferric Chloride-PDA (10%) R211348 Enterococcus/Grp A Strep Screen R21242 Nitrate Reagent B R21238 Ninhydrin Reagent R21233 Potassium Hydroxide (KOH) 20% w/glycerol RapID Staph Plus Panels M. Cat. Butyrate Disk Pathotec CO Gram-Sure Disk SPS Disk Micro-ID Listeria Identification System RapID Nitrate A Reagent RapID Nitrate B Reagent Oxichrome Reagent Legionella Kit Buffer RapID Spot Indole Reagent CT0998B BLANK DISCS DD0030S Oxoid™ Bacitracin Diagnostic Discs Acridine Orange R07674 Fuji Medium (10ml) 100/PK Multiple RapID NH System RIM E.coli O157:H7 Latex R01822 Spectra MRSA 100/PK R01821 Spectra MRSA 10/PK Spectra MRSA R2451020 Xpect Cryptosporidium Xpect Cryptosporidium R01272 Campy CVA Medium R01270 Campy CVA Medium Colistin Disk Haemophilus Identification Kit MUG Disk V3030 Sensititre™ OptiRead™ R40121 Methanol (absolute) R01176 BHI Agar w/Vanc (6ug) BHI w/6mg Vancomycin RapID SS/u System R064812 Todd Hewitt Broth w/CNA (LIM) R064810 Todd Hewitt Broth w/CNA (LIM) R24650 Xpect C. diff Toxin A/B KT/20TST R24640 Xpect C. diff Toxin A/B KT/40TST Xpect Clostridium Diff. Toxin A/B Niacin Control Disk R21508 BactiDrop Desoxycholate R20304 10B Broth R20302 10B Broth,Lyophilized R064141 Regan Lowe Semi-Solid Transport 20/PK R08524 LJ w/Ferric Ammonium Citrate R08526 LJ Med w/5% Ferric Ammon Cit R01349 Cystine Chocolate HI Agar Multiple Porphyrin Reagent R40110 TB Methylene Blue BTL/250ml R40210 TB Methylene Blue TB Methylene Blue R723135 Liquid Stuarts,Wire Shaft PK/50 R723130 Liquid Stuarts,Wire Shaft Swab PK/100 R723115 Liquid Stuarts,Single Swab PK/50 R723125 Liquid Stuarts,Dual Swab PK/50 R723120 Liquid Stuarts,Dual Swab PK/500 R723110 Liquid Stuarts,Single Swab PK/500 Rifampin Disk Sensititre Supplemented Brucella Broth R01653 OFPBL Medium R01859 Strep Selective II Agar R01858 Strep Selective II Agar Formalde-Fresh Solution, Buffered, Fisher Chemical Prefilled Containers, 10% NBF Prefilled Dermatology Containers, 10% NBF Neutral Buffered Formalin 10% 20% Buffered Formalin Concentrated Neutral Buffered Formalin Formalin, Buffered, 10% (Phosphate Buffer/Certified) Blue Formalin R21923 Formalin 10% Formalin, Buffered, 10% (Acetate Buffer/Certified) HandiPack Containers, 10% NBF R21640 Formalin 10%, Syntri Safeguard, 10% NBF Prostate Kits ALIF Buttress Plate R246303 DMSO Mod Acid Fast Stain Kit R40186 TB Auramine O R40034 D'Antoni's Iodine BTL/1gallon R21528 BactiDrop Lugol's Iodine R40124 Sulfuric Acid (1%) R40017 Dienes stain BTL/25ml R40190 TB Auramine-Rhodamine O R40107 TB Decolorizer Truant Moore R40092 TB Potassium Permanganate R40063 Crystal Violet (1%) BTL/1 gallon R40217 Trichrome Stain Kit, R40112 TB Kinyoun AFB Stain Kit R40042 Basic Fuchsin (1.2%) Shandon Acid-Fast Bacillus Stain R40192 TB Potassium Permanganate R40028 Lactophenol Aniline Blue Acid-Fast Bacillus Stain Blue Secondary Stain Kit R40101 TB Bril Green R40200 TB Bril Green R40219 Trichrome Quick Stain Kit R40086 TB Auramine O (Fluorescent) R40073 Gram Crystal Violet BTL/1 gallon, Stain, R40075 Gram Decolorizer BTL/1 gallon R40055 Gram Decolorizer R40094 TB Auramine O Stain Kit R40208 TB Malachite Green Gram Stain (Tissue) Kit Multiple R40052 Grman Crystal Violet BTL/250ml R40108 TB Malachite Gree R2463418 DMSO Mod Acid Fast Decolorizer BTL/1 gallon R40207 TB Decolorizer, Truant-Moore R40053 Gram Crystal Violet BTLx5/250ml Acid-Fast Bacillus Stain Green Secondary Stain Kit R40090 TB Auramine-Rhodamine T-BTL/250ml R40029 Lugol's Iodine, R40027 Lactophenol Steiner-Steiner Kit R40080 Gram Stain Set 4x250ml w/Tray R40168 Gram Decolorizer (95% alcohol) BTL/1 gallon Modified Grocott's Methenamine Silver (Chromic Acid) Kit R40213 Trichrome Blue Modified Grocott's Methenamine Silver (Periodic Acid) Kit R40054 Gram Decolorizer R40180 Acridine Orange, Phenolic R40025 Trichrome Stain, Wheatley BTL/250ml Gram Stain (Film) Kit Niacin Reagent Strip R21518 BactiDrop India Ink Bacticard Candida R21540 BactiDrop Oxidase Candida albicans Disk C. Albicans disk Hippurate Disk RapID ANA II System R21502 BactiDrop Acridine Orange BactiDrop Acridine Orange Pyridoxal Disk Beta Lysin Disk R07681 Haemophilus Test Medium Broth R20044 Haemophilus Test Medium Broth Haemophilus Test Medium Broth VersaTREK Myco PZA Kit R01561 MacConkey w/Sorbitol R01556 MacConkey w/Sorbitol R01503 Haemophilus Test Medium (100mm) 10/PK R04033 Haemophilus Test Medium (150mm) 10/PK Haemophilus Test Medium R40102 TB Ziehl-Neel Carbolfuchsin BFL/250ml Carbol Fuchsin-Kinyoun Solution (Heat Technique) Carbol Fuchsin-Ziehl Neelsen Solution Carbol Fuchsin-Kinyoun Solution (Cold Technique) R40202 TB Ziehl-Neel Carbolfuchsin Carbon Fuchsin CARBOL FUCHSIN Bacticard E.coli Kanamycin Disk Penicillin Disk Bile Disk R40077 Gram Iodine R40057 Gram Iodine R40056 Gram Iodine Gram Iodine R12569 M6 MicroTip Flock Swab Kit R12568 M6Traditional FlockSwab Kit R12563 M6 Universal Flock Swab Kit R12562 M6(1.5ml)Universal Flock Swab Kit R12561 M6(1.5ml)MicroTip Flock Swab Kit R12557 M6Traditional Swab Kit R12533 M6 R12530 M6 A.L.A. Disk R01284 Campy Blood Agar R01280 Campy Blood Agar R04067 RPMI w/MOPS RPMI w/MOPS R21510 BactiDrop Dobell & O'Connor Iodine R04052 MH Agar R01622 MH Agar w/5% Sheep Blood R09598 MH Broth w/Cations R01626 MH Agar w/4% NaCl,6ug Oxacillin R04050 MH Agar R01620 MH Agar (100mm) 10/PK R061470 MH Broth R061472 MH Broth R04055 MH Agar w/5% Sheep Blood R04057 MH Agar w/5% Sheep Blood R01624 MH Agar R07128 MH Broth w/Cations R061478 MH Broth R09592 MH Agar (25ml deep) MH Agar w/4% NaCl,6ug Oxacillin R07097 Diamonds Medium,Modified Mueller Hinton Broth T3462-05 MUELLER-HINTON BROTH W/TES 5ml 100/BOX T3462 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES CP112-10 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood CP11410 Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood T3491 Sensititre Saline- Tween w/ Glass Beads T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC T3441 Sensititre Middlebrook 7H9 Broth w/OADC R060370 Campy Thio Medium w/Agar R060372 Campy Thio Medium w/Agar LAP Disk w/Reagent R21538 BactiDrop Nitrate B Mycobacti-LoopsTM CFUrine KitsTM RapID STR System Multiple RapID NF Plus System Gram's Iodine Solution R21278 Zinc PVA Fixative R21927 Zinc PVA Fixative R21765 Zinc PVA Fixative R060070 Amies Transport Medium w/Charcoal 100/PK R060062 Amies Transport Medium w/oCharcoal 20/PK R064622 Stuart Transport Med w/o Charcoal 20/PK R060072 Amies Transport Medium w/Charcoal 20/PK Sensititre GP Panel MB1561A Microbact Staph 12S MB1588A Microbact Staph Fast Blue Reagent M. pneumoniae IgG/IgM Antibody Oxy-Swab Multiple R21534 BactiDrop Ninhydrin Catarrhalis Test Disk Multiple R2450001 ProSpecT™ Wash Buffer R120170 BactiSwab™ (Dry) CS/500 R120160 BactiSwab™ (Dry) CS/100 BactiStaph Latex Aniline Blue Stain R062085 PYR Broth (0.5ml) R01310 Clostridium Difficile Agar R01318 CNA w/Blood R01322 Columbia CNA w/5% Sheep Blood R20305 10B Arginine Broth Bacticard Strep R01460 GC Agar Base R04030 GC Agar Base GC Agar Base RapID Yeast Plus System R8323600 ERIC (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM) PYR/Esculin Disk R40222 Gram Iodine PVP R40061 Gram Iodine PVP Gram Iodine PVP R01585 MRS Agar R01862 SXT Blood Agar R10067 Dermatophyte Test Medium R01236 Blood Agar w/Neomycin(60mcg) 10/PK R01564 MacConkey CT-Sorbitol 10/PK R02401 Avian Quad Plate R09542 MacConkey Agar R20203 A7 Agar w/Putrescine R01227 Blood Agar w/Gent(10mcg) R01328 Cornmeal Agar w/PS80 R01552 MacConkey Agar R02150 Cetrimide/Vogel John Biplate R09538 MacConkey w/o Crystal Violet R01231 Blood Agar w/Neomycin(10mcg) R01558 MacConkey w/o Crystal Violet R02180 Anaer CNA/Brucella LKV Biplate R09290 Cornmeal Agar w/PS80 R09680 RIOT Agar R01266 CCFA Modified Agar w/Horse Blood R02041 Blood/EMB,Levine Biplate R01865 TCBS Agar R20202 A7 Agar R01104 B Frag Isolation Agar R01405 EMB Agar,Modified R02092 MacConkey/Mannitol Salt Biplate R060302 Bile Esculin Azide Broth R01710 Pseudomonas F Agar R07102 EC Broth w/DT R01962 Vibrio Detection Agar R02066 Columbia CNA w/5% SB/Mac Biplate R01194 Bile Esculin Azide Agar R01299 CGB Agar R01550 MacConkey Agar R02144 Tergitol 7 w/TTC/Blood Biplate R01856 Strep A Isolation Agar R01583 Mannitol Salt Agar w/4ug Oxacillin R01861 SXT Blood Agar R09979 Yeast Ext Phosphate Agar R92207 SP4 Glucose Agar,Diphasic R01481 HE Agar (Hektoen Enteric) Agar R01616 Molybdate Agar R07089 Listeria Enrichment Broth R01190 Bile Esculin Agar R01269 CCFA-ST R02050 Blood/MacConkey Biplate R02136 Anaer Reduc LKV/Reduc Bld w/N,V R01191 Bile Esculin Agar R01180 BiGGY Agar,Nickerson R01282 Candida BCG Agar R02060 Columbia CNA w/5% SB/EMB Biplate R01441 Esculin Iron Agar R01590 McCarthy Agar R02140 Salmonella Shigella/XLD Biplate R20276 SP4 Glucose Agar R02126 Anaer Reduc LKV/PEA w/Vit K Biplate R061338 MacConkey Broth R01189 Bile Esculin Azide Agar R01268 CCFA Modified Agar R01480 HE Agar (Hektoen Enteric) R02049 Blood/MacConkey Biplate R02135 Anaer Reduc CNA/Reduc LKV Biplate R01615 Mitis Salivarius Agar R064582 Salmonella Shigella Agar R01053 Anaer LPV Blood Agar R01402 EMB Agar,Levine R01192 Birdseed Agar R01292 Cetrimide Selective Agar R01541 MRL Red Agar R02088 Anaer Reducible CNA/KBE Biplate R02063 Columbia Blood/MacConkey Biplate R02142 SXT Blood/SXT Blood Biplate R20376 SP4 Glucose Broth R01044 Anaer LKV Blood Agar R01365 Dermatophyte Test Medium R01982 XLD Agar R02077 Columbia CNA/EMB,Levine Biplate R01980 XLD Agar R02068 EMB Agar,Levine/MacConkey Biplate R01712 Pseudomonas Isolation Agar R01108 Baird Parker Agar R01243 Bovine Blood w/Esculin R01576 MacConkey w/Ceftazidime R01406 EMB Agar,Modified R02124 Anaer Reducible Bld/PEA w/SB,Vit K R060734 Cystine Tellurite Bld Agar R07910 Trich/Yeast Broth R01845 Staph 110 Medium R02006 Anaer Reduc LKV/B Frag(BBE)Biplate R01857 Strep Selective Agar R060292 Bile Esculin Agar R01245 B Cepacia Selective Agar R09832 TCBS Agar R20211 A7 Agar w/Phenol Red R01580 Mannitol Salt Agar R01860 SXT Blood Agar R09897 Tinsdale Agar Base R01056 McClung Toabe Agar R01403 EMB Agar,Levine R01228 Blood Agar w/Neomycin(30mcg) R02089 Anaer Reducible LKV/KBE Biplate R20433 Mycoplasma Broth III R01348 Cystine Tellurite Blood Agar R060294 Bile Esculin Agar R01247 Bril Green Agar w/Novobiocin R01557 MacConkey Agar R02176 CDC Blood/B Frag (BBE) Biplate R02040 Blood/EMB,Levine Biplate R01867 Strep Selective Agar R08462 Littman Oxgall Agar R09548 MacConkey w/Sorbitol R02065 Columbia CNA w/5% SB/Mac Biplate R20204 A8 Agar,Selective R01864 Strep Selective Agar R20201 A7 Agar R01045 Anaer LKV Blood Agar R01246 Bril Green Agar R01855 Strep A Isolation Agar R01400 EMB Agar,Levine R02010 Bile Esculin/BHI w/6.5%NaCl Biplate R02086 HE (Hektoen Enteric)/XLD Biplate R01840 Salmonella Shigella Agar R01998 Yersinia Sel (CIN) Agar R01483 HE Agar (Hektoen Enteric) R01709 Burkholderia Cepacia Agar R07100 EC Broth w/DT R01806 Schaedler LKV Agar R01983 XLD Agar w/20mg/L Novo R08352 Dermatophyte Test Medium CM0007B MACCONKEY AGAR, CM0617B Bacillus cereus Selective Agar Base (PEMBA) CM0227B Desoxycholate Citrate Agar (Hynes) Multiple Spectra™ Candida Agar R01833 R12515 M5 R12516 M5 R12555 M5Traditional Swab Kit R12580 M5Universal Swab Kit Microtest M5 Transport VersaTREK 7110-44 VERSATREK REDOX 2M, EZ DRAW 40ML 7106-44 VERSATREK REDOX 1, 40 ML W/STIR BAR 7103-44 VERSATREK REDOX 2, 80ML 7103-44M VERSATREK REDOX 2M 80ML 7112-42 VERSATREK MYCO GS 7104-44 VERSATREK REDOX 80ML TWIN-PACK 7111-42 VERSATREK MYCO BOTTLES 7102-44 VERSATREK REDOX 1, 80 ML W/STIR BAR 7107-44 VERSATREK REDOX 2, EZ DRAW 40ML 7111-42M VERSATREK MYCO BOTTLES, W/MODIFIED CAP Y52814 VERSATREK 528 W/14 DRAWERS/CTRL MOD Y52818220 VERSATREK 528 W/18 DR/CTRL MOD 220V Y52820 VERSATREK 528 W/20 DRAWERS/CTRL M Y24008 VERSATREK 240 W/8 DRAWERS/CTRL MOD Y24010220 VERSATREK 240 W/10 DR/CTRL MOD 220V Y52822220 VERSATREK 528 W/22 DR/CTRL MOD 220V Y24004220 VERSATREK 240 W/4 DR/CTRL MOD, 220V Y52818 VERSATREK 528 W/18 DRAWERS/CTRL MOD Y52816 VERSATREK 528 W/16 DRAWERS/CTRL MOD Y52822M VERSATREK M 528 W/22 DRAWERS 7114-42 VERSATREK MYCO AS Y24010 VERSATREK 240 W/10 DRAWERS/CTRL MOD Y24008220 VERSATREK 240 W/8 DR/CTRL MOD, 220V Y24006220 VERSATREK 240 W/6 DR/CTRL MOD, 220V Y52822 VERSATREK 528 W/22 DRAWERS/CTRL MOD Y24004 VERSATREK 240 W/4 DRAWERS/CTRL MOD 7150-44 VersaTREK™ CONNECTOR 7113-42 VERSATREK MYCO PVNA R21522 BactiDrop Indole,Kovac's R21550 BactiDrop Spot Indole R242007 PROSPECT GIARDIA PAB 1MG R242028 PROSPECT GIARDIA MAB 1MG GIARDIA SPP. MUTIPLE Microdase Disk R21730 SAF Fixative (15ml Vial) PK/12 R21732 SAF/Empty Vial PK/6SET R21921 SAF Fixative (15ml Vial) PK/120 R21710 PVA Modified Fixative Color Slide II Mononucleosis Test R40015 Calcofluor White Stain Kit Caffeic Acid Disk R01186 Bile Esculin Azide Agar w/6ug Vanc Bile Esculin Azide with Vancomycin R01187 Bile Esculin Azide Agar w/6ug Vanc 100PK R40079 Gram Safranin Safranin O Solution Gram Safranin R40058 Gram Safranin R40059 Gram Safranin Legionella Pneumophilia 1 Legionella Species Tests Kit DrySpot Legionella Pneumo.Serogroup 2-14 Legionella Latex Agglut. Tests Kit Legion. Pneumophilia Reag. Kit DrySpot Legionella Species Legion. Pneumophilia 2-14 Kit R24600 Xpect Flu A&B R21560 BactiDrop VP-A (alpha napthol 5%) R01342 BCYE Agar R060286 BHI Broth w/6.5% NaCl R20806 Tetrathionate Broth R062582 Phos Buffered Saline R060992 GN Broth R064508 Selenite Broth w/Cystine R060988 GN Broth R08380 GN Broth R064503 Selenite Broth R07160 Tetrathionate Broth R064844 Todd Hewitt Brothw/Gent,NA,SB R060990 GN Broth R064506 Selenite Broth w/Cystine R064840 Todd Hewitt Broth w/Gent,NA R07162 Tetrathionate Broth R062620 Potassium Chloride Solution(4.5ml) R064842 Todd Hewitt Broth w/Gent,NA R060936 Fletchers Med w/o 5% Fluorauracil R07161 Tetrathionate Broth w/BG R07754 Nutrient Broth,7% NaCl R08382 GN Broth R060284 BHI Broth w/6.5% NaCl CM0009B PEPTONE WATER, CM0733B Maximum Recovery Diluent CM0699B SELENITE CYST.BROTH BASE R2451030 Xpect Cryptosporidium Control Cryptosporidium Spp. R01662 PEA w/5% Sheep Blood R10105 LJ Mycobactocel R01148 BHI w/SB,CGC R01542 MRL Green Agar R01630 Mycobiotic Agar (Mycocel) R10048 BHI w/SB,CGC R01507 Inhibitory Mold Agar R08576 Mitchison 7H11 Selective R01509 Inhibitory Mold Agar w/Cipro,Vanc R08602 Mycobiotic Agar (Mycocel) R10044 BHI Agar w/SB,Chlor,Gent R01470 Haemophilus Isolation w/Bacitracin R08520 LJ Gruft R01261 Brucella Agar w/Horse Blood,TVP R01333 BCYE w/BTB, BCP & PAV R01356 CNA w/SB,Col,NA,Amp B,Gent,Vanc R01063 Anaer Reducible CNA Bld Agar R08410 Inhibitory Mold Agar R01954 VACC Agar R061336 MacConkey Broth R08724 Sab Dex Agar,Emmons w/Chlor R01704 Potato Flake Agar w/Cipro,Vanc R060274 BHI Broth w/1ug Ciproflo 5ml 20/PK R241055 Mycobiotic Agar (MycoTube) R20260 PPLO Agar R01754 SABHI Agar w/Chlor,Cyclo R08072 BHI Agar w/SB,Chlor,Gent (slant) 20/PK R08816 TCH Agar,5mcg/ml R01506 Inhibitory Mold Agar w/Gent R08574 Mitchison 7H11 Selective R09322 Czapek Medium R01660 PEA w/5% Sheep Blood R10102 LJ Gruft R01049 Anaer PEA Blood Agar R01610 Mitchison 7H11 Selective R01733 Rose Agar R08742 Sab Dex,Emmons w/Chlor,Gent R10158 Sab Dex Agar,Emmons w/Chlor R01502 Inhibitory Mold Agar w/Gent(26ml) 100/PK R07020 Bril Green Bile Broth,2% w/DT R01043 Anaer KV Blood Agar R01600 Middlebrook 7H10 Agar R08734 Sab Dex,Emmons w/Cyclo R01317 Chocolate w/Vanc,Serum (Nairobi) R01478 HBT Bilayer Medium R08522 LJ Gruft R01048 Anaer PEA Blood Agar R01608 Middlebrook 7H11 Agar w/Myco J R08738 Sab Dex Agar,Emmons w/Gent R10155 Sab Dex Agar,pH 5.6 R01543 MRL Yellow Agar R08215 CEA Agar w/CGC R08699 SABHI w/Sheep Blood,Chlor R01505 Inhibitory Mold Agar R08532 LJ Mycobactocel R09300 BCYE Agar (22ml deep) 20/PK R08080 BHI w/SB,CGC (slant) 20/PK R01274 Campy Selective Medium R01341 BCYE w/PAV R02112 Middlebrook 7H11/Mitchison7H11 Sel R08078 BHI w/SB,CGC (slant) 100/PK R01575 Catarrhalis Selective Medium R08726 Sab Dex Agar,Emmons w/Chlor R241067 Sab Dex Emmons w/Chlor,Gent R01123 BHI Agar w/SB,Chlor,Gent R01279 Campy Chocolate w/TVAP R01769 Sab Dex, Emmons w/Chlor R01144 BHI Agar w/SB,Chlor,Gent R01294 Charcoal Selective Medium R01776 Sab Dex Agar,Emmons w/Gent R064844 Todd Hewitt Brothw/Gent,NA,SB R01160 BHI w/SB,Pen,Strep,Yst Ext R01646 Mycobiotic Agar (Mycocel) R10070 Inhibitory Mold Agar R01168 BHI Agar w/Fildes,Bacitracin R10082 Jones Kendrick Transport R01350 Czapek Medium Plate R08298 Cottonseed Agar R08703 SABHI Agar w/Sheep Bld,Gent R01304 Chocolate Agar w/Bacitracin R01508 Inhibitory Mold Agar R08600 Mycobiotic Agar R01338 BCYE w/DGVP R01258 Brucella w/5% SB,TVP (Skirrow) R01703 Potato Flake Agar w/Chlor,Cyclo R07022 Bril Green Bile Broth,2% w/DT R10130 Mycobiotic Agar R08068 BHI Agar w/Chlor,Cyclo (slant) 100/PK R01298 Charcoal Bld Agar (Regan Lowe) R01790 Sab Dex,pH 5.6 w/Chlor R01346 Cystine Heart Agar R08070 BHI Agar w/SB,Chlor,Gent R08608 Mycological Agar R01142 BHI Agar w/SB,Chlor,Cyclo R01772 Sab Dex,Emmons w/Chlor,Gent R01050 Anaer PV Blood Agar R01612 Mitchison 7H11 Selective 16/PK R01740 Rogosa Agar R08812 TCH Agar,1mcg/ml R110131 Cetrimide Selective Agar 100/PK R01140 BHI Agar w/SB,Chlor R01771 Sab Dex,Emmons w/Chlor,Cyclo R01812 Spectra Strep A agar Multiple R111030 Contact I Mycological w/Lec,PS80 20/PK RapID ONE System Cary-Blair w/Ind PRAS Cary-Blair Cary-Blair/Glycerol Saline R05038 PRAS Cary-Blair Mod HC PRAS Cary-Blair Mod HC PVA Modified R31610 Cary-Blair Orange w/Ind (15ml Vi) PK/12 R21650 Glycerol Saline R21617 Cary-Blair w/Ind R21610 Cary-Blair w/Ind R21949 Cary-Blair w/Ind/Empty Vial R21616 Cary-Blair w/Ind/Empty R21924 PVA Modified R31925 Cary-Blair Orange w/Ind (15ml Vi) PK/120 R21968 PVA-Mod/Form/Cary-Blair w/Ind R05039 PRAS Cary-Blair R21925 Cary-Blair w/Ind R40104 TB Kinyoun Carbolfuchsin BTL/250ml R40204 TB Kinyoun Carbolfuchsin TB Kinyoun Carbolfuchsin Xpect RSV R01339 BCYE w/PAC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2009-12-01
HYF Giemsa Stain Hematology Class 1 864.1850 1997-01-28
JSS Kit, Identification, Enterobacteriaceae Microbiology Class 1 866.2660 2012-11-14
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2008-12-04
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2026-04-09
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2026-04-09
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2026-04-09
JXC Kit, Screening, Yeast Microbiology Class 1 866.2660 1998-02-24
JTS Stains, Microbiologic Hematology Class 1 864.1850 2012-11-19
JXB Kit, Identification, Yeast Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JSG Culture Media, Non-Selective And Non-Differential Microbiology Class 1 866.2300 1978-06-21
JSF Culture Media, Single Biochemical Test Microbiology Class 1 866.2320 2012-11-19
JSX Kit, Identification, Neisseria Gonorrhoeae Microbiology Class 1 866.2660 2012-11-14
MHI Giardia Spp. Microbiology Class 2 866.3220 2009-12-01
JSI Culture Media, Selective And Differential Microbiology Class 1 866.2360 2012-11-19
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2012-11-19
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2012-11-19
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JSX Kit, Identification, Neisseria Gonorrhoeae Microbiology Class 1 866.2660 1996-05-01
PPM General Purpose Reagent Pathology Class 1 864.4010 2005-02-24
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2005-05-31
IDC Acridine Orange Hematology Class 1 864.1850 2012-11-19
JWZ Kit, Screening, Trichomonas Microbiology Class 1 866.2660 2012-11-20
JSX Kit, Identification, Neisseria Gonorrhoeae Microbiology Class 1 866.2660 2012-11-14
GNA Antisera, All Types, Escherichia Coli Microbiology Class 1 866.3255 2012-11-14
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2010-11-24
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2009-12-01
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 2012-11-19
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2014-08-18
JTS Stains, Microbiologic Hematology Class 1 864.1850 2012-11-19
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2009-12-01
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2014-07-14
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2014-07-14
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2014-07-14
JSS Kit, Identification, Enterobacteriaceae Microbiology Class 1 866.2660 2012-11-14
JSD Culture Media, Selective Broth Microbiology Class 1 866.2360 2012-11-19
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2009-12-01
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JSN Culture Media, Propagating Transport Microbiology Class 1 866.2390 2008-12-04
KZI Culture Media, Enriched Microbiology Class 1 866.2330 1996-05-01
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTS Stains, Microbiologic Hematology Class 1 864.1850 2012-11-19
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2025-06-16
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JSC Culture Media, General Nutrient Broth Microbiology Class 1 866.2350 2024-01-08
JSI Culture Media, Selective And Differential Microbiology Class 1 866.2360 2012-11-19
JSI Culture Media, Selective And Differential Microbiology Class 1 866.2360 2012-11-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-02-01
IFP Formalin, Neutral Buffered Pathology Class 1 864.4010 1995-06-21
JTS Stains, Microbiologic Hematology Class 1 864.1850 1998-02-24
MJD Culture Media, Antimycobacteria, Susceptibility Test Microbiology Class 2 866.1700 2012-11-14
JTS Stains, Microbiologic Hematology Class 1 864.1850 2012-11-19
JXB Kit, Identification, Yeast Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JXC Kit, Screening, Yeast Microbiology Class 1 866.2660 2012-11-14
JTC Device, Microtiter Diluting/Dispensing Microbiology Class 1 866.2500 2012-11-14
JSP Kit, Anaerobic Identification Microbiology Class 1 866.2660 2012-11-14
JFO Fluorometric, Calcium Clinical Chemistry Class 2 862.1145 2012-11-19
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2009-12-01
MJA Susceptibility Test Powders, Antimycobacterial Microbiology Class 2 866.1640 2011-12-19
JSI Culture Media, Selective And Differential Microbiology Class 1 866.2360 2012-11-19
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2008-12-04
ICL Carbol Fuchsin Hematology Class 1 864.1850 1997-01-28
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
HYI Iodine, Grams Hematology Class 1 864.1850 2012-11-19
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2009-12-01
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2014-07-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 2012-11-19
MJE Culture Media, Antifungal, Susceptibility Test Microbiology Class 2 866.1700 2010-11-24
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2008-12-04
KZI Culture Media, Enriched Microbiology Class 1 866.2330 2012-11-19
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2011-12-13
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 2012-11-19
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JTR Kit, Quality Control For Culture Media Microbiology Class 1 866.2480 1992-08-17
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JSE Culture Media, Multiple Biochemical Test Microbiology Class 1 866.2320 1978-06-21
JSW Kit, Identification, Glucose Nonfermenter Microbiology Class 1 866.2660 2012-11-14
HYI Iodine, Grams Hematology Class 1 864.1850 1997-01-28
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2009-12-01
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2014-08-15
LQL Gram Positive Identification Panel Microbiology Class 1 866.2660 2011-12-19
LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. Microbiology Class 1 866.3375 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
IGB Solution, Formalin-Sodium Acetate Pathology Class 1 864.4010 1998-02-24
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2007-05-04
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2024-08-06
JWX Kit, Screening, Staphylococcus Aureus Microbiology Class 1 866.2660 2012-11-14
KFD Aniline Blue Hematology Class 1 864.1850 1997-01-28
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JSI Culture Media, Selective And Differential Microbiology Class 1 866.2360 2012-11-19
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2009-12-01
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTY Culture Media, For Isolation Of Pathogenic Neisseria Microbiology Class 2 866.2410 2008-12-04
JXB Kit, Identification, Yeast Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JSI Culture Media, Selective And Differential Microbiology Class 1 866.2360 1978-06-21
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2009-12-01
MDB System, Blood Culturing Microbiology Class 1 866.2560 2011-12-13
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2013-05-06
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
MHI Giardia Spp. Microbiology Class 2 866.3220 2005-10-27
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-14
IGB Solution, Formalin-Sodium Acetate Pathology Class 1 864.4010 2009-12-01
LDX Fixative, Metallic Containing Pathology Class 1 864.4010 1997-09-09
KTN System, Test, Infectious Mononucleosis Immunology Class 2 866.5640 2008-03-11
JTS Stains, Microbiologic Hematology Class 1 864.1850 2012-11-19
JSF Culture Media, Single Biochemical Test Microbiology Class 1 866.2320 2012-11-14
NGZ Susceptibility Test Plate, Antifungal Microbiology Class 2 866.1640 2014-07-14
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2009-12-01
HZS Safranin Hematology Class 1 864.1850 1997-01-28
MJH Legionella, Spp., Elisa Microbiology Class 2 866.3300 2005-11-10
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2009-12-01
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2012-11-19
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 2012-11-19
JSD Culture Media, Selective Broth Microbiology Class 1 866.2360 1978-06-21
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2005-10-27
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 1978-06-21
JSS Kit, Identification, Enterobacteriaceae Microbiology Class 1 866.2660 2012-11-14
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2013-07-18
JTS Stains, Microbiologic Hematology Class 1 864.1850 2012-11-19
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2021-02-26
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 2012-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thermo Fisher Scientific
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010455511 Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd Suzhou Jiangsu, CN
3006190736 LABOMEX MBP TIJUANA Baja California, MX
2517925 FISHER SCIENTIFIC COMPANY L.L.C. PITTSBURGH, PA, US
3006440892 OXOID AUSTRALIA PTY LIMITED THEBARTON South Australia, AU
1314344 Nalge Nunc International Corporation Rochester, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812581 Uti-Tect, Inc. SENSI-TECT 1981-09-23
K760790 General Diagnostics MICRO-ID 1976-10-29
K770926 Analytical Products, Inc. SUSPENSION SALINE, API 20E 1977-06-17
K010508 Pasco Laboratories, Inc. PASCO MIC AND MIC/ID PANELS 2001-04-23
K111394 Siemens Healthcare Diagnostics, Inc. MICROSCAN MICROSTEP 2011-06-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-05 Remel, Inc. 1
Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.
Z-0015-2008 Thermo Fisher Scientific 1
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
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-0011-2008 Pml Microbiologicals Inc. 2
Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Z-0014-2008 Pml Microbiologicals Inc. 2
Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174

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8010096 OXOID, LTD. BASINGSTOKE, HAMPSHIRE, GB
1111096 BECTON, DICKINSON & CO. Cockeysville, MD, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1924669. Last updated year: 2026. Please use registration number 1924669 when referencing this establishment in official correspondence.
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