HARDY DIAGNOSTICS

FDA Registration(s)#

GUDID Contact Samples#

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

• hardydiagnostics.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• HardyDisk AST Gepotidacin 10µg (GEP10)

  2025-06-26

  Hardy Diagnostics

• HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)

  2025-05-15

  Hardy Diagnostics

• Viral Transport Medium

  2024-08-02

  Hardy Diagnostics

• HardyDisk AST Cefiderocol 30µg (FDC30)

  2024-07-18

  Hardy Diagnostics

• HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)

  2023-07-06

  Hardy Diagnostics

• HardyDisk AST Rezafungin 5µg (RZF5)

  2023-06-01

  Hardy Diagnostics

• HardyDisk AST Cefiderocol 30ug (FDC30)

  2020-01-23

  Hardy Diagnostics

• HardyDisk AST Lefamulin 20µg (LMU20)

  2019-09-19

  Hardy Diagnostics

• HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)

  2019-07-31

  Hardy Diagnostics

• HardyCHROM CRE

  2019-04-29

  Hardy Diagnostics

• HardyDisk AST Omadacycline 30µg (OMC30)

  2019-01-18

  Hardy Diagnostics

• HardyDisk AST Eravacycline 20µg (ERV20)

  2018-09-26

  Hardy Diagnostics

• HardyDisk AST Plazomicin 30ug (PLZ30)

  2018-07-10

  Hardy Diagnostics

• Granada Medium

  2018-03-22

  Hardy Diagnostics

• HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)

  2017-10-03

  Hardy Diagnostics

• HardyDisk AST Delafloxacin 5 µg (DLX5)

  2017-08-01

  Hardy Diagnostics

• Strep B Carrot Broth One-Step

  2017-05-22

  Hardy Diagnostics

• Strep B Carrot Broth Kit

  2017-05-16

  Hardy Diagnostics

• HardyDisk Ceftolozane/Tazobactam, (30/10 Ug)-C/T40

  2017-03-14

  Hardy Diagnostics

• HardyCHROM ESBL

  2016-11-15

  HARDY DIAGNOSTICS

• HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40

  2015-11-24

  HARDY DIAGNOSTICS

• HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50

  2015-11-24

  HARDY DIAGNOSTICS

• HARDYCHROM MRSA

  2011-05-04

  HARDY DIAGNOSTICS

• HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939

  2010-12-17

  HARDY DIAGNOSTICS

• HARDYDISK AST TELAVANCIN,30UG

  2010-01-08

  HARDY DIAGNOSTICS

• HARDYDISK AST DORIPENEM 10 UG

  2008-01-29

  HARDY DIAGNOSTICS

• HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936

  2006-08-23

  HARDY DIAGNOSTICS

• HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883

  2001-06-13

  HARDY DIAGNOSTICS

• HARDKYDISK NEOMYCIN, 30 MCG

  2001-05-18

  HARDY DIAGNOSTICS

• HARDYDISK BACITRACIN, 10MCG, MODEL Z927

  2001-04-26

  HARDY DIAGNOSTICS

• HARDYDISK SULFISOXAZOLE

  2001-01-25

  HARDY DIAGNOSTICS

• HARDYDISK TRIMETHOPRIM 5MCG

  2001-01-19

  HARDY DIAGNOSTICS

• HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG

  2001-01-17

  HARDY DIAGNOSTICS

• HARDYDISK NAFCILLIN, 1 MCG

  2001-01-12

  HARDY DIAGNOSTICS

• HARDYDISK RIFAMPIN, 5MCG

  2001-01-12

  HARDY DIAGNOSTICS

• HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG

  2001-01-12

  HARDY DIAGNOSTICS

• HARDY DISK, CEFPODOXINE, 10MCG

  2000-12-13

  HARDY DIAGNOSTICS

• HARDYDISK CLINDAMYCIN, 2MCG

  2000-11-02

  HARDY DIAGNOSTICS

• HARDYDISK LOMEFLOXACIN, 10MCG

  2000-10-26

  HARDY DIAGNOSTICS

• HARDYDISK LEVOFLOXACIN, 5MCG

  2000-10-26

  HARDY DIAGNOSTICS

107 records. Showing 1-40. Next

GUDID#

• N/A - Wilkins-Chalgren Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Wilkins-Chalgren Agar is recommended for the cultivation and isolation of anaerobic microorganisms and for the preparation of agar dilution tests.

  HARDY DIAGNOSTICS

  2020-05-20

• N/A - BiGGY Agar Slant (Nickerson's Agar), 6ml, 16x125mm tube, order by the package of 10 For the selective isolation and identification of Candida spp.

  HARDY DIAGNOSTICS

  2022-11-15

• N/A - All Purpose Quad Plate (Eosine Methylene Blue (EMB) Agar / Mannitol Salt Agar (MSA) / Mycobiotic Agar / Blood Agar, 5%), 15x100mm Quadplate, 5ml/section. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Mannitol Salt Agar (MSA) is recommended for use as a selective and differential medium for the isolation of pathogenic staphylococci. Hardy Diagnostics Mycobiotic Agar is recommended for use in the isolation of pathogenic fungi from clinical specimens.

  HARDY DIAGNOSTICS

  2020-05-24

• N/A - Lowenstein Jensen Medium, 20x125mm Tube, 5ml Deep. Hardy Diagnostics Lowenstein Jensen Deep is recommended for use in the semiquantitative catalase test to aid in differentiation of Mycobacterium species.

  HARDY DIAGNOSTICS

  2020-05-13

• QuickSlide™ - GramPRO 3, Automated Gram Stain Instrument. Intended to be used to perform a Gram stain sequence on slides containing biological specimens in preparation for subsequent microscopic analysis. For in vitro diagnostic use.

  HARDY DIAGNOSTICS

  2021-11-04

• HardyDisk - HardyDisk AST Tebipenem, 10ug (TBP10), 1x50 disks. For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales to tebipenem.

  HARDY DIAGNOSTICS

  2026-10-09

• HardyDisk™ - HardyDisk™ AST Tebipenem, 10ug (TBP10), 5 x 50 disks For in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales to tebipenem.

  HARDY DIAGNOSTICS

  2026-10-09

• N/A - ALP(Aerobic Low Peptone) Arabinose, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli

  HARDY DIAGNOSTICS

  2020-06-09

• HardyDisk™ - HardyDisk™ AST Gepotidacin, 10ug (GEP10), 5 x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin.

  HARDY DIAGNOSTICS

  2025-08-08

• HardyDisk™ - HardyDisk™ AST Gepotidacin, 10ug (GEP10), 1x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin.

  HARDY DIAGNOSTICS

  2025-08-08

• NA - "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."

  HARDY DIAGNOSTICS

  2016-09-01

• N/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.

  HARDY DIAGNOSTICS

  2020-05-18

• N/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.

  HARDY DIAGNOSTICS

  2024-07-08

• N/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.

  HARDY DIAGNOSTICS

  2020-06-08

• N/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.

  HARDY DIAGNOSTICS

  2020-08-06

• N/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.

  HARDY DIAGNOSTICS

  2020-06-08

• N/A - PPLO Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics PPLO Media are recommended for the cultivation and maintenance of Mycoplasma spp. and Ureaplasma spp.

  HARDY DIAGNOSTICS

  2020-05-18

• N/A - Purple Broth Base (control), 9ml, 16x125mm tube with durham tube, order by the package of 20A control tube for the fermentation of carbohydrates.

  HARDY DIAGNOSTICS

  2020-06-08

• N/A - Purple Broth with Mannitol, 10ml, 16x125mm tube with durham tube, order by the package of 20For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.

  HARDY DIAGNOSTICS

  2020-06-09

• N/A - Purple Broth with Sucrose, 10ml fill, 16x125mm tube with durham tube, order by the package of 20For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.

  HARDY DIAGNOSTICS

  2020-06-09

• N/A - Purple Broth Base (control), 9ml, 16x125mm tube with durham tube, order by the package of 20 A control tube for the fermentation of carbohydrates.

  HARDY DIAGNOSTICS

  2020-06-08

• N/A - GN Broth, 12x80mm tube, 4ml fill, order by the package of 100For the selective enrichment of Salmonella and Shigella spp. in stool specimens.

  HARDY DIAGNOSTICS

  2020-06-05

• HardyFlask™ - Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species.

  HARDY DIAGNOSTICS

  2020-06-08

• N/A - Pyruvate Broth, 5ml, 15x103mm , optically clear, shatter resistant, polycarbonate tube, order by the package of 20For the determination of pyruvate utilization in bacteria.

  HARDY DIAGNOSTICS

  2020-06-09

• N/A - GN Broth, 12x80mm tube, 4ml fill, order by the package of 100 For the selective enrichment of Salmonella and Shigella spp. in stool specimens.

  HARDY DIAGNOSTICS

  2020-06-05

• HardyFlask™ - Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species.

  HARDY DIAGNOSTICS

  2020-06-08

• N/A - "NaCl 6.5% Agar Slant, salt tolerance agar, 6.5ml, 16x100mm tube, order by the package of 20(Brain Heart Infusion Agar with 6.5% NaCl without indicator, ""Salt Tolerance Agar"") For the identification of Enterococcus spp."

  HARDY DIAGNOSTICS

  2020-06-03

• N/A - Phenol Red Broth with Maltose, 10ml, 16x125mm tube with durham tube, order by the package of 20For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.

  HARDY DIAGNOSTICS

  2020-06-09

• 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

• HardyDisk™ - HardyDisk™ AST Gepotidacin, 10ug (GEP10), 1x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin.

  HARDY DIAGNOSTICS

  2025-08-08

• N/A - ALP(Aerobic Low Peptone) Urea, Modified, 3ml slant, 13x100mm tube, order by the package of 10For the identification of non-fermentative bacilli

  HARDY DIAGNOSTICS

  2020-06-09

• N/A - ALP(Aerobic Low Peptone) Xylose, Modified, 3ml fill, 13x100mm tube, order by the package of 10For the identification of non-fermentative bacilli

  HARDY DIAGNOSTICS

  2020-06-09

• HardyDisk™ - HardyDisk™ AST Aztreonam-Avibactam 30 / 20ug (AZA50),1 x 50 disksFor in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales to Aztreonam/Avibactam

  HARDY DIAGNOSTICS

  2025-07-18

• HardyDisk™ - HardyDisk™ AST Aztreonam-Avibactam 30 / 20ug (AZA50),5 x 50 disksFor in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales to Aztreonam/Avibactam

  HARDY DIAGNOSTICS

  2025-07-14

• HardyDisk™ - HardyDisk™ AST Aztreonam-Avibactam 30 / 20ug (AZA50),5 x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales to Aztreonam/Avibactam

  HARDY DIAGNOSTICS

  2025-07-14

• QwikID - QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. 20 cassettes, ID 00816576027439;20 Sample preparation tubes, ID 00816576028030 and 1 Positive control reagent, ID 00816576028047

  HARDY DIAGNOSTICS

  2025-06-23

• 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

• QwikID - QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. 20 cassettes, ID 00816576027439;20 Sample preparation tubes, ID 00816576028030 and 1 Positive control reagent, ID 00816576028047

  HARDY DIAGNOSTICS

  2025-06-23

• N/A - Carbon Utilization Base Slant, (control) 8ml, 20x125mm tube, order by the package of 20Hardy Diagnostics Carbon Utilization Media with added carbon sources are recommended for use in the cultivation and differentiation of a wide variety of rapidly growing mycobacteria.

  HARDY DIAGNOSTICS

  2020-06-09

• N/A - Carbon Utilization with Inositol Slant, 8ml, 20x125mm tube, order by the package of 20Hardy Diagnostics Carbon Utilization Media with added carbon sources are recommended for use in the cultivation and differentiation of a wide variety of rapidly growing mycobacteria.

  HARDY DIAGNOSTICS

  2020-06-09

200 records. Showing 1-40. Next