| Primary Device ID | 00816576026715 |
| NIH Device Record Key | 188ed713-ec91-4465-8ea6-83b98c2f88ff |
| Commercial Distribution Discontinuation | 2018-09-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | 293824 |
| Catalog Number | 293824 |
| Company DUNS | 039981550 |
| Company Name | HARDY DIAGNOSTICS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 |
| 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 |