| Primary Device ID | 00816576020195 |
| NIH Device Record Key | 8136c154-938c-4039-b336-5ad5d4ddbc49 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | J44 |
| Catalog Number | J44 |
| Company DUNS | 039981550 |
| Company Name | HARDY DIAGNOSTICS |
| Device Count | 10 |
| DM Exempt | false |
| 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 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816576020195 [Primary] |
| GS1 | 00816576021338 [Unit of Use] |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria |
| 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 | 2016-09-02 |
| 00816576027958 - N/A | 2026-02-06 Liver Infusion Agar Selective, 15x100mm plate, order by the package of 10 (Liver Infusion Selective Agar with Polymyxin B, Nalid |
| 00819398024594 - N/A | 2026-02-04 Purple Broth Base (control), 9ml, 16x125mm tube with durham tube, order by the package of 20 A control tube for the fermentation |
| 00819398023603 - N/A | 2026-01-30 GN Broth, 12x80mm tube, 4ml fill, order by the package of 100 For the selective enrichment of Salmonella and Shigella spp. in st |
| 00819398024235 - HardyFlask™ | 2026-01-30 Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended fo |
| 00816576027088 - HardyDisk™ | 2025-08-18 HardyDisk™ AST Gepotidacin, 10ug (GEP10), 1x 50 disks For in vitro agar diffusion susceptibility testing when there is the nee |
| 00816576026975 - HardyDisk™ | 2025-07-22 HardyDisk™ AST Aztreonam-Avibactam 30 / 20ug (AZA50),5 x 50 disks For in vitro agar diffusion susceptibility testing when ther |
| 00816576027439 - QwikID | 2025-07-01 QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antig |
| 00819398027199 - N/A | 2025-03-18 Anaerobe Nitrate Reagent A, Sulfanilic Acid for nitrate reduction test, 15ml, formulated especially for anaerobic bacteria Hardy |