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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
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- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2022807
- DUNS Number
- —
Catalogue (356)
Page 7 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cvm Transport, Model R96, Viral Transport, Model R99, Cvm Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K | K993812 | FDA 510(k) | Class I | Active |
| Granada Medium | K173903 | FDA 510(k) | Class I | Active |
| Hardy Disk Ceftizoxime, 30mcg | K002367 | FDA 510(k) | Class II | Active |
| Hardydisk Erythromycin, 15mcg | K994135 | FDA 510(k) | Class II | Active |
| HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | K152846 | FDA 510(k) | Class II | Active |
| Hardydisk, Kanamycin, 30mcg | K000203 | FDA 510(k) | Class II | Active |
| Hardydisk Trimethoprim 5mcg | K003554 | FDA 510(k) | Class II | Active |
| Hardy Disk Clarithromycin, 15mcg | K001728 | FDA 510(k) | Class II | Active |
| Oxystrip | K930693 | FDA 510(k) | Class I | Active |
| Strep B Carrot Broth One-Step | K170586 | FDA 510(k) | Class I | Active |
| Hardydisk, Tetracycline 30mcg | K000304 | FDA 510(k) | Class II | Active |
| Hardydisk Ticarcillin/Clavulanic Acid, 85mcg | K003686 | FDA 510(k) | Class II | Active |
| HardyCHROM ESBL | K160512 | FDA 510(k) | Class II | Active |
| Hardydisk Cefoperazone, 75 Mcg | K001489 | FDA 510(k) | Class II | Active |
| Hardy Disk, Penicillin, 10 Units | K000302 | FDA 510(k) | Class II | Active |
| Hardydisk, Vancomycin 30mcg | K000509 | FDA 510(k) | Class II | Active |
| HardyDisk AST Cefiderocol 30µg (FDC30) | K241060 | FDA 510(k) | Class II | Active |
| Hardy Disk, Cefpodoxine, 10mcg | K003532 | FDA 510(k) | Class II | Active |
| Hardydisk, Piperacillin, 100mcg | K000183 | FDA 510(k) | Class II | Active |
| HardyDisk AST Eravacycline 20µg (ERV20) | K182357 | FDA 510(k) | Class II | Active |
| HardyDisk AST Cefiderocol 30ug (FDC30) | K193504 | FDA 510(k) | Class II | Active |
| HardyDisk AST Cefiderocol 30µg (FDC30) | K253105 | FDA 510(k) | Class II | Active |
| Hardydisk, Sulfa/Trimeth | K000271 | FDA 510(k) | Class II | Active |
| HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 | K170127 | FDA 510(k) | Class II | Active |
| Vogues-Proskauer Reagent A & B | K930720 | FDA 510(k) | Class I | Active |
| Hardydisk, Cefazolin, 30mcg | K000128 | FDA 510(k) | Class II | Active |
| Hardydisk Sulfisoxazole | K003690 | FDA 510(k) | Class II | Active |
| HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | K231568 | FDA 510(k) | Class II | Active |
| Hardydisk, Carbenicillin, 100mcg | K000181 | FDA 510(k) | Class II | Active |
| Pyr Test Kit | K931865 | FDA 510(k) | Class I | Active |
| HardyDisk AST Delafloxacin 5 µg (DLX5) | K171975 | FDA 510(k) | Class II | Active |
| HardyDisk AST Omadacycline 30µg (OMC30) | K183298 | FDA 510(k) | Class II | Active |
| Hardydisk, Cefoxitin, 30mcg | K000305 | FDA 510(k) | Class II | Active |
| Hardydisk Aztreonam, 30mcg | K994063 | FDA 510(k) | Class II | Active |
| Hardydisk Streptomycin, 300mcg | K002368 | FDA 510(k) | Class II | Active |
| Cvm Transport | K955451 | FDA 510(k) | Class I | Active |
| Hardydisk, Streptomycin 10mcg | K000201 | FDA 510(k) | Class II | Active |
| Hardydisk Netilmicin, 30mcg | K002663 | FDA 510(k) | Class II | Active |
| Hardydisk, Cefotaxime 30mcg | K000524 | FDA 510(k) | Class II | Active |
| Hardkydisk Neomycin, 30 Mcg | K011385 | FDA 510(k) | Class II | Active |
| Hardydisk Ast Telavancin, 30ug | K093807 | FDA 510(k) | Class II | Active |
| Hardydisk, Ampicillin, 10mcg | K000268 | FDA 510(k) | Class II | Active |
| Hardydisk Novobiocin, 30mcg, Model Z883 | K011384 | FDA 510(k) | Class II | Active |
| Bile Spot Reagent | K931530 | FDA 510(k) | Class II | Active |
| Hardydisk Cefixime, 5mcg | K994129 | FDA 510(k) | Class II | Active |
| Hardydisk, Ciprofloxacin, 5mcg | K000258 | FDA 510(k) | Class II | Active |
| Hardydisk Cefotetan, 30mcg | K002661 | FDA 510(k) | Class II | Active |
| Ferric Chlorid Reagent, 10% | K931413 | FDA 510(k) | Class I | Active |
| Parakit | K941110 | FDA 510(k) | Class I | Active |
| HardyCHROM CRE | K190553 | FDA 510(k) | Class II | Active |
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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. |