Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2022807

FEI Number

2022807

Entity Name

HARDY DIAGNOSTICS

City/State/Country

Orcutt, CA, US

Establishment Address

1430 WEST MCCOY LN., Orcutt, CA 93455, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

HARDY DIAGNOSTICS (Owner Number: 2022807)

Owner / Operator Contact Address

1430 West McCoy Lane, --, Santa Maria, CA 93455, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HardyDisk Clindamycin HEMOPHILUS ID QUAD PLATE HardyDisk Aztreonam/Avibactam HardyDisk Sulfamethoxazole/Trimethoprim HardyDisk Sulfmethanoxazole.Trimeth ONPG Rapid Ornithine Nitrate Substrate Broth Motility Nitrate Trehalose Fermentation Broth Jordan's Tartrate Deep Rapid Urea Medium MGP Broth OF Medium with carbo CTA Media Arylsulfatase MR-VP Broth Phenol Red Media Phenylalanine Agar LanaGram Rapid bacterial gram reaction Test Rapid Trehalose Broth Rapid MGP Media HardyDisk Doxycycline HardyDisk Azithromycin HardyDisk Imipenem HardyDisk Gepotidacin BHI Agar w/Vancomycin HardyDisks AST Ceftazidime/Avibactam HardyDisk Piperacillin/Tazobac HardyDisk Cefotaxime Martin Lewis w/Lincomycin Thayer Martin Mod. Agar Thayer Martin w/VCN NNN Medium Base Page's Saline, 2ml Todd Hewitt Broth Tryptic Soy Broth Tryptic Soy Broth, Filtered Sabdex Broth Thio w/o Indicator Alkaline Peptone Water Phenol Red Broth Base Brucella Broth FB Broth Brain Heart Infusion Broth AnaeroGro PYG Broth Thio W/Indicator Todd Hewitt Br w/0.5%Y Ex Naegleria Broth BHI Broth Page's Saline Todd Hewitt w/Tween Nutrient Broth HardyCHROM ESBL Mueller Hinton Agar Mueller Hinton Broth Mueller Hinton Agar with Blood MRSA Screen Plate Mueller Hinton Agar with Chocolate HardyDisk Amoxicillin HardyDisk Amoxicillin/Clavulanic Acid HardyDisk Plazomicin HardyDisk Ofloxacin Immersion Oil AFB Smear Fix Indole Nitrate Broth MIL Medium RSU Broth (sucrose-urea) MIO Medium Rapid Anginosus ID Kit Rapid Urea/Esculin Kit ONPG-PDA HardyDisk Nalidixic Acid HardyDisk Ceftaroline HardyDisk Cefazolin HardyDisk Penicillin HardyDisk Omadacycline HardyDisk Streptomycin Strep B Carrot Broth One-Step McFarland Latex Equiv 6 McFarland Latex Equiv 7 McFarland Latex Equiv 5 McFarland Latex Equiv. 0 McFarland Standards Set McFarland Latex Equiv 0.5 McFarland Latex Equiv 4 McFarland Latex Equiv 1 McFarland Latex Equiv 3 Snyder Test Agar McFarland Latex Equiv 2 McFarland Latex Equiv 8 HardyDisk Nitrofurantoin CatScreen Moellers Arginine Decarb Saline 0.45% Saline 0.85% HardyDisk Bacitracin HardyDisk Trimehtomprim HardyDisk Trimethoprim HardyDisk Sulfisoxazole HardyDisk Chloramphenicol Coagulase Cryo HardyDisk AST Cefiderocol 30ug (Fdc30) OF Base Medium TSA Plate Potato Flake Agar Nutrient Agar Plate Nutrient Agar Slant Columbia Agar YM Agar Agar Deep, 1.5% Tryptic Soy Agar Slant Nutrient Agar 1.5% SabHI Agar Non-Nutrient Agar BHI Agar Potato Dextrose Agar Slant TSA Slant Malt Extract Agar HardyFlask Sabdex Agar Sabdex Agar Potato Dextrose Agar Tryptic Soy Agar Sabdex Agar, Emmons Malt Ext Agr w/01% chl TSA w/6% Yeast Extract BHI Agar Deep Sabdex Agar Slant BHI Agar Slant TSA Deep SabHI Agar Slant MycoVue PFA Potato Dextrose Agar Deep Sabdex Agar, Deep MRSA Screen Plate HardyDisk Piperacillin Mueller Hinton Agar with Chocolate hardydisk ast rezafungin 5µg (rzf5) GramPRO 1 Gram stain control slides Q-Slide AFB Q-Slide, Pro bond Q-Slide-Gram HardyDisk Imipenem/Relebactam HardyDisk Oxacillin HardyDisk Oxicillin Transgrow Granada Medium AnaeroGro LKV Agar INHIBITORY MOLD AGAR COL. CNA MYCOBIOTIC AGAR AnaeroGro Campy Selective Agar GN BROTH V Agar w/CNA Sabdex Agar w/Chloram. Middlebrook 7H11 Sel SabHI Ag w/Bl,Chlor&Cyclo BCYE Selective Agar w/CAV Campy CVA Agar Regan-Lowe Semi Solid LJ Gruft Slant Campy Selective Agar BHI Agar w/Chloramphenicol & Gentamicin Malt Extract Agar w/01% Rose Agar (CNA+PEA) BCYE Selective Agr w/CCVC LKV Agar Regan-Lowe Agar BHI Broth w/Ciprofloxacin AnaeroGroTM Campy Selective Agar Peptic Digest Agar w/F&N M.catarrhalis Sel. Agar Campy Cefex Agar,Modified BHI Agar w/Blood & Gent. Inhib.Mold Agar Slant Campy,Blood Free, Karmali Group A Beta Strep Agar LJ w/NaCl Slant LJ w/Pyruvate LJ Media Slant PDA w/Chloramphenicol Basic Fuchsin BHI Agar w/Chlr&Cyc LJ Deep Malt Extract w/Chloramph. SabdexAgar w/Chlor&Tetra Campy Blood Agar StrePlate AnaeroGroTM Anaerobic PEA Agar Columbia CNA Agar AnaeroGroTM LKV Agar Campy FDA Agar BHI Agar w/Bld, Chlr&Gent Sabdex Agar w/G & C Potato Flake Select. Agar PEA w/5% Sheep Blood PPLO Selective Broth PPLO Broth Blood Agar w/Ampicillin Inhib.Mold Agar w/Genta Chocolate Agar w/Vanco. Middlebrook 7H11, Selecti PPLO Selective Agar PLET Agar GBS Detect Campy Thioglycollate Chocolate Agar w/Bacitrac Neomycin Anaerob Bld Agar Cat. No. W25 Inhib.Mold Agar Potato Dextrose Agar with TA Wallenstein Slant BCYE w/GPVC, 26ml Inhibitory Mold Agar LJ Selective Slant AnaeroGro Anaerobic PEA Selenite Cystine Broth Selective Strep Agar Potato Dextrose Agar with Chloramphenicol Stanford Potato Agar CAN Agar BCYE w/GVPC w/o Cysteine BCYE w/VPC CNA w/Esculin Agar EMMONS SABDEX HardyDisk Cefoxitin HardyDisk Carbenicillin HardyDisk Amikacin HardyDisk Eravacycline HardyDisk Norfloxacin HardyDisk Levofloxacin Martin Lewis w/Lincomycin CarboFerm Neisseria Kit Phosphate buffer AlbiQuick StrepQuick Test Card GlabrataQuick Kit StrepQuick Kit Phosphate buffered saline Tryptone Broth 2% Modified ALP with carbohydrate Trichophyton #3 Nutrient Gelatin Pseudomas Isolation Agar Starch Agar Trichophyton #4 Nitrate broth with DT Egg Yolk Agar, Modified Tech Agar Slant FID Agar Slant for NFB Lysine Iron Agar(LIA) Slt TSB with 6.5% NaCl AnaeroGro Egg Yolk Agar, modified KIA Slant Dermatophyte Milk Agar Acetate Differential Slnt Casein Agar Motility w/TTC Medium Pseudomonas Agar P Simmons Citrate Agar Slant Enteroscreen4 for SS TSI Agar Slant Corn Meal Agar w/Tween 80 Esculin Agar Slant Urea R Broth,1ml Motility Test Medium Litmus Milk Broth Modified ALP with supplement Motility Test Agar Nocardia Hydrolysis Kit Pseudomonas Agar F Trichophyton #5 Acetamide Agar Slant Trichophyton #2 AnaeroGroTM Egg Yolk Agar HardyCHROM UTI Malonate Broth Urea Agar Slant Trichophyton #1 DNAse w/o Indicator GramPRO 1 Reagent Kit GramPRO 3 Stain Kit Methylene Blue Stain, Loeffler's 15ml Hardy Diagnostics Loeffler's 15ml ParaCon Funnel Filter ParaCon Filter Funnels HardyDisk Tigecycline HardyDisk Cefaclor Mueller Hinton Broth HTM Agar HemaPRO ProBond Slide Pro Slides Microscope Slides Methyl Red Test Reagent Nitrate Reagent A OxiStrips, oxidase test Catalase Reagent,H2O2 15% PYR Test Kit AFB Nitrate Reagent B OxiDrops, oxidase test Nitrocef Matchbook Indole, DMACA Spot Potassium Hydroxide, KOH Indole, Kovacs Reagent Modified Field's Stain Oxidase Powder CAMP Spot Test Rgnt Nitrate Reagent C Nitrate Reagent B Voges-Proskauer Reagent B AFB Nitrate Reagent A HardyDisk Novobiocin 5ug HardyDisk Kanamycin 1000mcg HardyDisk ONPG HardyDisk X Factor HardyDisk Nitrocef HardyDisk Colistin Sulfate HardyDisk Vancomycin 5ug HardyDisk Blank HardyDisk SPS HardyDisk Bile HardyDisk Optochin HardyDisk Bacitracin HardyDisk XV Factor HardyDisk V Factor HardyDisk ALA HardyDisk Nitrate Catalase Reagent, 3% Indoxyl Acetate Disks HardyDisk Lysostaphin Hippurate Disks PYR Reagent Lactophenol Cotton Blue Ferric Chloride, 10% Germ Tube Cryo, Caffeic Acid Disks Ninhydrin Reagent BlueMount OxiSticks Oxidase Swabs Bile Spot Test Anaerobe Nitrate Rgt B Voges-Proskauer Reagent A HCL,50% Concentr. Sol Anaerobe Nitrate Rgt A HardyDisk Novobiocin Viral Transport Medium TransPRO MacConkey w/Cipro Acanthamoeba Broth, 5ml LIM Broth for GrpB Strep Selenite Cystine Broth SIM Medium MacConkey w/DT C. auris Enrichment Broth BHI with Cipro Lim Broth Hajna TT Broth Bile Esculin Azide Broth Diamonds Medium, Modified HardyDisk Tetracycline HardyCHROM CRE LifeScale Gram Negative (LSGN) kit HardyDisk Cefotetan HardyDisk Lefamulin Moellers Decarb Base HardyDisk Tobramycin HardyDisk Cefuroxime Fecal Concentrator Kit II Fecal Concentrator Kit HardyDisk Gentamicin HardyDisk Ampicillin/Sublactam HardyDisk Amicillin.Sulbactam HardyDisk Ceftriaxone Moellers Ornithine Decarb Cetrimide Select Agar HardyCHROM Candida MacConkey Agar Deep EMB Agar (HHT) Strep B Carrot Broth Kit HardyCHROM Salmonella AnaeroGro CCFA MSA w/Oxacillin CGB Agar CLED Agar Mannitol Salt Agar DTM Agar Slant Vogel and Johnson Agar SP4 Agar w/Arginine SP4 Broth w/Arginine Bile Esculin Azide Agar Baird Parker Agar Granada Medium BBE Agar MacConkey Agar w/Sorbitol Sulfite Polymyxin Milk Ag MacConkey Agar (RSR) A8 for Mycoplasma BiGGY Agar Slant SF Broth Lowenstein Jensen w/Iron Bile Esculin Agar, BEA Bile Esculin Agar Slant CIN (Yersinia) Agar HardyCHROM Staph aureus BCSA, for B. cepacia HardyCHROM Group A Strep Agar Modified XLD Agar HardyCHROM Candida + auris HardyCHROM Campy Agar AnaeroGro BBE Agar CLED w/Bile Salts Derm-DuetTM, RSM BLUECOLI SP4 Broth w/Urea SP4 Agar w/Glucose HardyCHROM SS NoPRO Agar MacConkey Agar BEA with Azide NaCl 6.5% Broth w/o Ind. DTM Agar SS Agar Leeds Medium Bile Esculin Agar, Slant PC Agar TCBS Agar, for Vibrio CT-SMAC for E. coli 0157 HE Agar BCYE w/DGVP SP4 Broth w/Glucose Brilliant Green Agar Bile Esculin Agar HUrBi BiGGY Agar Caffeic Acid Agar EMB Levine Agar NaCl 6.5% Broth w/Indic. HardyDisk Erythromycin HardyDisk Erthromycin HardyCHROM MRSA Moellers Lysine Decarb Anaerobic Transport Medium NALC Powder Potassium Hydroxide, KOH Mayer's Albumin TB Prep Kit, RED Zephiran-TSP w/BTB Ind. TB Base Digestant Triton X-100 10% SoluPhyte, KOH+DMSO Sudan Black IV Stain Oxalic acid 5% UriStain MycoMount for wet mounts Iodine,Dobell & O'Conner India Ink TB Prep Kit MucoGest Decolorizer, Slow Water with Tween Sodium Carbonate, 2N HCL,50% Concentr. Sol Deionized Water Phosphate Buffer UriStain, 15ml Sodium Citrte 2.94% TB Digestant, RED Std Sampling Soln Zephiran-TSP Potassium Hydroxide 10% Tween 80, 10% Solution

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	2007-01-31
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2020-06-01
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-06-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	1992-12-09
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-07-02
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2013-01-09
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-02-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2010-06-22
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	Microbiology	Class 2	866.2410	2013-01-09
JSC	Culture Media, General Nutrient Broth	Microbiology	Class 1	866.2350	1992-12-09
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2017-03-06
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2012-04-24
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-01-31
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2018-11-19
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
LEB	Mounting Media	Pathology	Class 1	864.4010	2020-09-02
JSE	Culture Media, Multiple Biochemical Test	Microbiology	Class 1	866.2320	1992-12-09
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2011-11-14
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2019-01-24
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2010-06-22
PQZ	Gbs Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2017-08-21
JTA	Monitor, Microbial Growth	Microbiology	Class 1	866.2560	2013-01-15
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2020-06-25
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	2014-01-02
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2013-01-15
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-01-31
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-01-31
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-01-31
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTL	Plasma, Coagulase, Human, Horse And Rabbit	Microbiology	Class 1	866.2160	1999-01-27
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2026-04-30
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	1992-12-09
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2024-02-20
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2024-02-20
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-04-17
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2013-01-07
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2019-10-17
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	Microbiology	Class 2	866.2410	2024-05-09
PQZ	Gbs Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2018-11-26
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	1992-12-09
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2018-11-26
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	Microbiology	Class 2	866.2410	2024-05-09
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2013-01-07
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	1992-12-09
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2013-01-07
LKS	Device, Parasite Concentration	Microbiology	Class 1	866.2900	2025-02-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-01-31
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2024-02-20
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2022-09-14
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2001-08-08
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	1996-11-01
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-01-31
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2024-08-13
JSD	Culture Media, Selective Broth	Microbiology	Class 1	866.2360	2001-08-08
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2019-10-18
SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples	Microbiology	Class 2	866.1650	2024-11-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-11-06
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2010-06-22
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2019-09-19
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2014-01-02
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
LKS	Device, Parasite Concentration	Microbiology	Class 1	866.2900	2013-02-13
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	2014-01-02
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	1992-12-09
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-10-23
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2011-11-14
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	2014-01-02
JSL	Culture Media, Anaerobic Transport	Microbiology	Class 1	866.2390	2011-02-14
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2013-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HARDY DIAGNOSTICS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009547954	Hardy Diagnostics	Springboro, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002664	Hardy Diagnostics	HARDYDISK LEVOFLOXACIN, 5MCG	2000-10-26
K822995	Granite Diagnostics, Inc.	ANDRADES FERMENTATION MEDIA	1982-11-16
K880126	Hardy Media	LAURYL TRYPTOSE BROTH	1988-03-31
K821594	Hardy Media	UREA AGAR SLANT	1982-07-08
K790620	Anaerobe Systems	LOMBARD DOWELL BROTH MEDIUMW/TH REONINE	1979-04-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
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-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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2022807. Last updated year: 2026. Please use registration number 2022807 when referencing this establishment in official correspondence.