Is this your brand? Sign in to claim ownership.
Sign in to claim this brandHARDY DIAGNOSTICS
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1430 WEST MCCOY LN., Orcutt, CA, 93455
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2022807
- DUNS Number
- —
Catalogue (356)
Page 6 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hardy Disk Ast Tigecycline 15 Ug, Modelz936 | K062245 | FDA 510(k) | Class II | Active |
| HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | K250454 | FDA 510(k) | Class II | Active |
| Hardydisk Levofloxacin, 5mcg | K002664 | FDA 510(k) | Class II | Active |
| Hardydisk Ast Doripenem 10 Ug | K080019 | FDA 510(k) | Class II | Active |
| Hardydisk Doxycycline, 30mcg | K994051 | FDA 510(k) | Class II | Active |
| Hardydisk, Cephalothin 30mcg | K000526 | FDA 510(k) | Class II | Active |
| Hardydisk Bacitracin, 10mcg, Model Z927 | K011086 | FDA 510(k) | Class II | Active |
| Coliscreen | K961191 | FDA 510(k) | Class I | Active |
| Hardydisk Imipenem, 10mcg | K994132 | FDA 510(k) | Class II | Active |
| Hardydisk Cefamandole, 30mcg | K000022 | FDA 510(k) | Class II | Active |
| Catalase Reagent | K931414 | FDA 510(k) | Class I | Active |
| Hardydisk Chloramphenicol, 30mcg | K994089 | FDA 510(k) | Class II | Active |
| Viral Transport Medium | K233534 | FDA 510(k) | Class I | Active |
| Hardydisk, Ceftazidime, 30mcg | K000259 | FDA 510(k) | Class II | Active |
| HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | K152838 | FDA 510(k) | Class II | Active |
| Thayer Martin, Modified Pill Pocket | K934331 | FDA 510(k) | Class II | Active |
| Hardydisk Gentamicin, 120mcg | K002369 | FDA 510(k) | Class II | Active |
| Hardydisk Cinoxacin, 100 Mcg | K001487 | FDA 510(k) | Class II | Active |
| Hardydisk Ast Ceftaroline, 30 Ug Model Z939 | K103538 | FDA 510(k) | Class II | Active |
| Transgrow | K934330 | FDA 510(k) | Class II | Active |
| HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | K172621 | FDA 510(k) | Class II | Active |
| Hardychrom Mrsa | K102922 | FDA 510(k) | Class II | Active |
| Hardydisk Rifampin, 5mcg | K003537 | FDA 510(k) | Class II | Active |
| Hardydisk Cefaclor 30mcg | K994046 | FDA 510(k) | Class II | Active |
| Chromagar Candida | K960075 | FDA 510(k) | Class I | Active |
| Hardydisk Amikacin 30mcg | K993993 | FDA 510(k) | Class II | Active |
| Hardydisk Azithromycin 15mcg | K993994 | FDA 510(k) | Class II | Active |
| Martin Lewis With Linocmycin | K931864 | FDA 510(k) | Class II | Active |
| Hardydisk Tobramycin, 10mcg | K000182 | FDA 510(k) | Class II | Active |
| Hardydisk Lomefloxacin, 10mcg | K002660 | FDA 510(k) | Class II | Active |
| Indole Spot & Indole Kovacs Reagent | K930718 | FDA 510(k) | Class I | Active |
| Hardydisk Gentamicin, 10mcg | K994091 | FDA 510(k) | Class II | Active |
| Hardydisk, Nitrofurantoin | K000272 | FDA 510(k) | Class II | Active |
| HardyDisk AST Rezafungin 5µg (RZF5) | K230827 | FDA 510(k) | Class II | Active |
| Hardydisk Cefonicid, 30 Mcg | K001490 | FDA 510(k) | Class II | Active |
| Hardydisk Ofloxacin 5mcg | K000525 | FDA 510(k) | Class II | Active |
| Ninhydrin Reagent | K931862 | FDA 510(k) | Class I | Active |
| HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | K191931 | FDA 510(k) | Class II | Active |
| Hardydisk Cefuroxime, 30mcg | K002656 | FDA 510(k) | Class II | Active |
| Strep B Carrot Broth Kit | K170481 | FDA 510(k) | Class I | Active |
| Hardydisk Nafcillin, 1 Mcg | K003536 | FDA 510(k) | Class II | Active |
| Hardydisk Norfloxacin, 10mcg | K994150 | FDA 510(k) | Class II | Active |
| Hardy Disk Ampicillin/Sulbactam | K994067 | FDA 510(k) | Class II | Active |
| Nitrate Reagents A, B And C | K930717 | FDA 510(k) | Class I | Active |
| Culture Media, Antimicrobial Susceptibility Test | K951754 | FDA 510(k) | Class II | Active |
| HardyDisk AST Lefamulin 20µg (LMU20) | K192326 | FDA 510(k) | Class II | Active |
| Hardydisk Clindamycin, 2mcg | K002662 | FDA 510(k) | Class II | Active |
| HardyDisk AST Plazomicin 30ug (PLZ30) | K181700 | FDA 510(k) | Class II | Active |
| Hardydisk Ticarillin 75mcg | K000175 | FDA 510(k) | Class II | Active |
| Hardydisk Mezlocillin 75mcg | K994212 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (19)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 6, 2025 | Z-2041-2025 | — | open, classified | Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. |
| Apr 16, 2021 | Z-1835-2021 | — | terminated | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. |
| Dec 21, 2020 | Z-0919-2021 | — | terminated | Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. |
| Oct 23, 2020 | Z-0655-2021 | — | terminated | There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing. |
| Oct 6, 2020 | Z-0441-2021 | — | terminated | Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10 |
| Nov 14, 2019 | Z-2298-2020 | — | terminated | False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited. |
| May 24, 2016 | Z-2146-2016 | — | terminated | Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. |
| Mar 21, 2016 | Z-1571-2016 | — | terminated | Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration. |
| Nov 18, 2015 | Z-0470-2016 | — | terminated | The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination. |
| Jul 9, 2015 | Z-2463-2015 | — | terminated | Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot. |
| Jun 26, 2015 | Z-2277-2015 | — | terminated | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. |
| Jun 26, 2015 | Z-2276-2015 | — | terminated | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. |
| Jun 26, 2015 | Z-2274-2015 | — | terminated | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. |
| Jun 26, 2015 | Z-2279-2015 | — | terminated | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. |
| Jun 26, 2015 | Z-2273-2015 | — | terminated | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. |
| Jun 26, 2015 | Z-2278-2015 | — | terminated | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. |
| Jun 26, 2015 | Z-2275-2015 | — | terminated | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. |
| Jun 24, 2015 | Z-2192-2015 | — | terminated | Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. |
| Mar 4, 2015 | Z-1444-2015 | — | terminated | The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot. |