| Primary Device ID | 00819398024235 |
| NIH Device Record Key | 32d34551-3973-49ca-85a8-7e23c22a449f |
| Commercial Distribution Discontinuation | 2026-01-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HardyFlask™ |
| Version Model Number | X26 |
| Catalog Number | X26 |
| Company DUNS | 039981550 |
| Company Name | HARDY DIAGNOSTICS |
| Device Count | 20 |
| 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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™ | 2026-01-30Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20
Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species. |
| 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 |
| 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 |