| Primary Device ID | 00816576020256 |
| NIH Device Record Key | 7959ecb9-b012-47ee-a5a1-e257875418f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | K91 |
| Catalog Number | K91 |
| Company DUNS | 039981550 |
| Company Name | HARDY DIAGNOSTICS |
| Device Count | 20 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-266-2222 |
| techservice@hardydiagnostics.com | |
| Phone | 800-266-2222 |
| techservice@hardydiagnostics.com | |
| Phone | 800-266-2222 |
| techservice@hardydiagnostics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816576020256 [Primary] |
| GS1 | 00816576021260 [Unit of Use] |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-01 |
| 00819398027199 - N/A | 2025-03-18 Anaerobe Nitrate Reagent A, Sulfanilic Acid for nitrate reduction test, 15ml, formulated especially for anaerobic bacteria Hardy |
| 00819398027779 - N/A | 2025-03-18 Anaerobe Nitrate Reagent B, Cleve's Acid for nitrate reduction test, formulated especially for anaerobic bacteria Hardy Diagnost |
| 00816576023516 - N/A | 2025-02-19 DTM Agar (Dermatophyte Test Medium) A selective and differential medium for the detection and presumptive identification of derm |
| 00816576025800 - TransPRO | 2024-10-16 TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-ti |
| 00816576026951 - N/A | 2024-07-16 G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other micro |
| 00816576026586 - N/A | 2024-04-05 Hektoen Enteric (HE) Agar / SS Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective an |
| 00816576026876 - N/A | 2024-03-18 C. auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichme |
| 00819398021593 - N/A | 2024-01-23 BHI Broth, 4mL, 100 tubes/pack (Brain Heart Infusion Broth) For the cultivation of fastidious and nonfastidious microorganisms. |