FDA.reportPublic FDA data

HARDY DIAGNOSTICS

Matched from indexed company URL: Hardy Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20228072022807HARDY DIAGNOSTICS1Y2026-01-011430 WEST MCCOY LN. Orcutt CA US 93455
30095479543009547954Hardy Diagnostics1N2026-01-01429 S Pioneer Blvd Springboro OH US 45066

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00816576020058NA - "MARTIN LEWIS w/ LINCOMYCIN, PP(Martin Lewis Agar with lincomycin, reduced vancomycin, colistin, amphotericin, and trimethoprim) For the selective isolation of Neisseria gonorrhoeae. Petri plate has a ""pill pocket"" receptacle for the addition of a CO2 tablet. 10 tablets and 10 ziplock."800-266-2222techservice@hardydiagnostics.com
00816576024858N/A - PPLO Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics PPLO Media are recommended for the cultivation and maintenance of Mycoplasma spp. and Ureaplasma spp.800-266-2222techservice@hardydiagnostics.com
00816576024995N/A - Granada Medium, 15x100mm Plate, 19ml. Granada Medium is a selective and differential agar which is intended for the qualitative detection of Group B Streptococcus (GBS) from LIM Broth enrichment cultures of vaginal/rectal swabs from antepartum women following 18-24 hours of incubation.800-266-2222techservice@hardydiagnostics.com
00816576026968N/A - G Vag Starch Agar, 15x100mm Monoplate.For the selective isolation and differentiation of Gardnerella vaginalis from other microorganisms found in the female genitourinary tract.800-266-2222TechnicalServices@Hardydiagnostics.com
00816576027958N/A - Liver Infusion Agar Selective, 15x100mm plate, order by the package of 10 (Liver Infusion Selective Agar with Polymyxin B, Nalidixic acid and Vancomycin) For the selective isolation of fungi.800-266-2222techservice@hardydiagnostics.com
00816576027965N/A - Liver Infusion Agar Selective, 15x100mm plate, order by the package of 10(Liver Infusion Selective Agar with Polymyxin B, Nalidixic acid and Vancomycin) For the selective isolation of fungi.800-266-2222techservice@hardydiagnostics.com
00819398024600N/A - Purple Broth Base (control), 9ml, 16x125mm tube with durham tube, order by the package of 20A control tube for the fermentation of carbohydrates.800-266-2222techservice@hardydiagnostics.com
00819398028653N/A - CAMP Spot Test Reagent, Beta toxin for Group B Strep (Streptococcus agalactiae) or Listeria, 1.0ml, CryoVial, 20 per packageA liquid CAMP reagent derived from Staphylococcus hemolysin for the identification of group B Streptococci (Streptococcus agalactiae) or Listeria monocytogenes. Produces enhanced hemolysis. Results can be read in 20 to 60 minutes.800-266-2222techservice@hardydiagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
342631028651827K994150HARDYDISK NORFLOXACIN, 10MCGJTN2000-02-16
342631116231208K994135HARDYDISK ERYTHROMYCIN, 15MCGJTN2000-02-16
342631369765271K994134HARDYDISK OXACILLIN, 1MCGJTN2000-02-17
342631002833951K994132HARDYDISK IMIPENEM, 10MCGJTN2000-01-18
342631964959457K994091HARDYDISK GENTAMICIN, 10MCGJTN2000-02-11
342631155458212K994089HARDYDISK CHLORAMPHENICOL, 30MCGJTN2000-02-11
342631063615891K994067HARDY DISK AMPICILLIN/SULBACTAMJTN2000-01-14
342631136730898K994051HARDYDISK DOXYCYCLINE, 30MCGJTN2000-01-10
342631827606666K994046HARDYDISK CEFACLOR 30MCGJTN2000-02-01
342631516485552K993994HARDYDISK AZITHROMYCIN 15MCGJTN1999-12-21
342632031832543K993993HARDYDISK AMIKACIN 30MCGJTN1999-12-27
342631636056663K964560BHI W/VANCOMYCIN AGARJSO1997-01-15
342631698608373K961191COLISCREENJTO1996-06-17
342631113926659K960996M. CAT BUTYRATE DISKJTO1996-04-18
342631172523254K955451CVM TRANSPORTJSM1996-07-22
1408241172523254K955451CVM TRANSPORTJSM1996-07-22
342631971935747K951754CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TESTJSO1995-10-16
1408241971935747K951754CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TESTJSO1995-10-16
342631543636073K944847KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEMJSL1995-02-16
342631777648596K934331THAYER MARTIN, MODIFIED PILL POCKETJTY1993-12-21
1408241777648596K934331THAYER MARTIN, MODIFIED PILL POCKETJTY1993-12-21
342631958284932K934330TRANSGROWJTY1993-12-17
342631216572787K931864MARTIN LEWIS WITH LINOCMYCINJTY1993-12-15
342632012043041K880121MOELLERS DECARBOXYLASE, BASEJSH1988-03-31
1408242012043041K880121MOELLERS DECARBOXYLASE, BASEJSH1988-03-31
342631851104231K880120MOELLERS DECARBOXYLASE, LYSINEJSF1988-03-31
342631065814335K880119MOELLERS DECARBOXYLASE, ONITHINEJSF1988-03-31
342631674442352K880118MOELLOERS DECARBOXYLASE, ARGININEJSF1988-03-30
1408241674442352K880118MOELLOERS DECARBOXYLASE, ARGININEJSF1988-03-30
342631572056433K880105MULLER HINTON BROTHJTZ1988-03-30
342631689959420K870649MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)JTZ1987-04-14
342631913798622K870636HEMOPHILUS ID QUAD PLATEJSH1987-04-14
342631119426708K850553MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOCJTZ1985-03-11
342631193322374K821607MUELLER HINTON W/5% SHEEP'S BLOODJTZ1982-07-06
342631353741191K811646MUELLER HINTON AGARJTZ1981-07-02
1408241353741191K811646MUELLER HINTON AGARJTZ1981-07-02
342631757548275K253105HardyDisk AST Cefiderocol 30µg (FDC30)JTN2025-11-20
342631467696428K250956HardyDisk AST Gepotidacin 10µg (GEP10)JTN2025-06-26
342631513245941K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)JTN2025-05-15
342631016625941K233534Viral Transport MediumJSM2024-08-02
1408241016625941K233534Viral Transport MediumJSM2024-08-02
342631608599829K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)JTN2023-07-06
342631167419254K230827HardyDisk AST Rezafungin 5µg (RZF5)JTN2023-06-01
342632059362798K193504HardyDisk AST Cefiderocol 30ug (FDC30)JTN2020-01-23
342631978816906K192326HardyDisk AST Lefamulin 20µg (LMU20)JTN2019-09-19
342631809745564K191931HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)JTN2019-07-31
342631273830494K190553HardyCHROM CREJSO2019-04-29
1408241273830494K190553HardyCHROM CREJSO2019-04-29
342631136566925K183298HardyDisk AST Omadacycline 30µg (OMC30)JTN2019-01-18
342631431301024K182357HardyDisk AST Eravacycline 20µg (ERV20)JTN2018-09-26
342631873919076K181700HardyDisk AST Plazomicin 30ug (PLZ30)JTN2018-07-10
342632052421642K173903Granada MediumPQZ2018-03-22
1408242052421642K173903Granada MediumPQZ2018-03-22
342632021865217K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)JTN2017-10-03
342631944244673K171975HardyDisk AST Delafloxacin 5 µg (DLX5)JTN2017-08-01
342632016061145K170586Strep B Carrot Broth One-StepPQZ2017-05-22
1408242016061145K170586Strep B Carrot Broth One-StepPQZ2017-05-22
342631782686126K170481Strep B Carrot Broth KitPQZ2017-05-16
342631596984271K160512HardyCHROM ESBLJSO2016-11-15
1408241596984271K160512HardyCHROM ESBLJSO2016-11-15
342631373902956K152846HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40JTN2015-11-24
342631180657914K152838HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50JTN2015-11-24
342631066239605K103538HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939JTN2010-12-17
342631381366991K102922HARDYCHROM MRSAJSO2011-05-04
1408241381366991K102922HARDYCHROM MRSAJSO2011-05-04
342631379155641K093807HARDYDISK AST TELAVANCIN,30UGJTN2010-01-08
342631112857469K080019HARDYDISK AST DORIPENEM 10 UGJTN2008-01-29
342631756640846K062245HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936JTN2006-08-23
342631673131558K021420PARACON II/FECAL CONCENTRATOR IILKS2002-06-04
342631050565054K011400MRSA-SCREENMYI2002-03-27
342631130549751K011384HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883JTN2001-06-13
342631504402656K011086HARDYDISK BACITRACIN, 10MCG, MODEL Z927JTN2001-04-26
342632068411387K003690HARDYDISK SULFISOXAZOLEJTN2001-01-25
342631504952424K003556HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCGJTN2001-01-17
342631556466572K003554HARDYDISK TRIMETHOPRIM 5MCGJTN2001-01-19
342631713911615K002664HARDYDISK LEVOFLOXACIN, 5MCGJTN2000-10-26
342632015463920K002662HARDYDISK CLINDAMYCIN, 2MCGJTN2000-11-02
342632032430455K002661HARDYDISK CEFOTETAN, 30MCGJTN2000-10-26
342631578889177K002656HARDYDISK CEFUROXIME, 30MCGJTN2000-10-25
342631515730964K001728HARDY DISK CLARITHROMYCIN, 15MCGJTN2000-07-27
342631259966305K000526HARDYDISK, CEPHALOTHIN 30MCGJTN2000-04-13
342631038093687K000525HARDYDISK OFLOXACIN 5MCGJTN2000-04-07
342631690026159K000524HARDYDISK, CEFOTAXIME 30MCGJTN2000-04-07
342631385707516K000509HARDYDISK, VANCOMYCIN 30MCGJTN2000-04-07
342631672166440K000440HARDYDISK CEFTRIAXONE 30MCGJTN2000-04-07
342631632515315K000305HARDYDISK, CEFOXITIN, 30MCGJTN2000-03-31
342631797252897K000304HARDYDISK, TETRACYCLINE 30MCGJTN2000-03-29
342631817420468K000302HARDY DISK, PENICILLIN, 10 UNITSJTN2000-03-24
342631720146326K000272HARDYDISK, NITROFURANTOINJTN2000-04-07
342631013773700K000271HARDYDISK, SULFA/TRIMETHJTN2000-04-07
342631893115034K000268HARDYDISK, AMPICILLIN, 10MCGJTN2000-04-07
342631667610506K000261HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCGJTN2000-04-07
342631159685178K000259HARDYDISK, CEFTAZIDIME, 30MCGJTN2000-03-21
342631178779589K000258HARDYDISK, CIPROFLOXACIN, 5MCGJTN2000-03-21
342631622554571K000203HARDYDISK, KANAMYCIN, 30MCGJTN2000-03-21
342631018308587K000201HARDYDISK, STREPTOMYCIN 10MCGJTN2000-02-29
342631255578103K000183HARDYDISK, PIPERACILLIN, 100MCGJTN2000-02-28
342631029941798K000182HARDYDISK TOBRAMYCIN, 10MCGJTN2000-02-29
342631198580688K000181HARDYDISK, CARBENICILLIN, 100MCGJTN2000-03-02
342631631732274K000130HARDYDISK, NALIDIXIC ACID, 30MCGJTN2000-02-29
342631580821751K000128HARDYDISK, CEFAZOLIN, 30MCGJTN2000-02-18
342631022230640
1408241036055493
342631123749439
342631294096908
342631330747252
342631495721075
342631684103509
342631883544324
342632022890250
342632065102890
342631029687394
1408241029687394
342631036095072
342631039060037
1408241039060037
342631202669797
342631228168625
1408241228168625

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JTN612025-11-20
JSO92019-04-29
JTZ61988-03-30
PQZ52018-03-22
JSM42024-08-02
JTY41993-12-21
JSF41988-03-31
JSH31988-03-31
JTO21996-06-17
LKS12002-06-04
MYI12002-03-27
JSL11995-02-16

PMN#

107 records. Showing 1-40. Next

GUDID#

N/A - MycoVue™ Slide Culture System, Potato Flake Agar, ready-to-use, includes cover slip and humidifier, 5 trays per boxA ready-to-use slide culture system for the cultivation of fungi. Simplify your fungal slide cultures while saving money, reducing frustration, and eliminating preparation time. Desiccation is prevented with a built in humidity chamber and the culture can be incubated for long periods of time. Device fits conveniently on the microscope stage for easy observation without disturbing the fungal structures.

HARDY DIAGNOSTICS

2020-06-04

Nitrocef Matchbook™ - Nitrocef Matchbook™, chromogenic nitrocefin test for beta lactamase, on paper strip, 10 tests per packageNew Easy-to-Use MatchBook Format. Hardy Diagnostics now offers a more convenient way of testing ß-lactamase activity in bacteria. The new Nitrocef MatchBook™ is a rapid test that allows you to quickly pick your colonies and perform the test at the same time! Easier and faster than a disk!The rapid Nitrocef test consists of a paper match-stick that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms:• Neisseria gonorrhoeae• Haemophilus spp.• Moraxella (Branhamella) catarrhalis• Staphylococcus spp.• Enterococcus spp.• Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella)The rapid Nitrocef MatchBookTM can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. Now contains a larger reaction pad.

HARDY DIAGNOSTICS

2020-06-25

HardyDisk™ - Cefoxitin (FOX30)HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

HARDY DIAGNOSTICS

2016-09-02

HardyDisk™ - Cefoxitin (FOX30)HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

HARDY DIAGNOSTICS

2016-09-02

HardyDisk™ - Bacitracin 10units (B10)HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

HARDY DIAGNOSTICS

2016-09-01

200 records. Showing 1-40. Next