HardyDisk™
- Primary DI
- 00816576028313
- Brand
- HardyDisk™
- Company
- HARDY DIAGNOSTICS
- Model
- Z7031
- Catalog number
- Z7031
- Device description
- X Factor, HardyDisk™, Hemin disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 each Contains Hemin (X factor) for the speciation of Haemophilus.
- Published
- 2020-08-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00816576028320 | Primary | GS1 | 0 | |
| 00816576028313 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00816576028320 | 00816576028320 | 816576028320 | 0816576028320 |
| 00816576028313 | 00816576028313 | 816576028313 | 0816576028313 |
GMDN Terms
| Term | Definition |
|---|
| X factor differentiation disc IVD | One or multiple diagnostic discs impregnated with iron protoporphyrin or X factor, intended to be used in microbial testing for differentiation of the Haemophilus group of bacteria isolated from a clinical specimen by culture. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -20 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 039981550
- Device count
- 50
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00848838059865 | ^BM^ PK/50 OXIDASE TEST | REMEL, INC. | JTO | 2026-01-16 |
| 05032384188796 | Oxoid™ Bacitracin Diagnostic Discs | OXOID LIMITED | JTO | 2024-07-08 |
| 00810144911229 | Northeast Laboratory Services | Northeast Laboratory Services, Inc. | JTO | 2023-09-21 |
| 00810144911236 | Northeast Laboratory Services | Northeast Laboratory Services, Inc. | JTO | 2023-09-21 |
| 00810144911243 | Northeast Laboratory Services | Northeast Laboratory Services, Inc. | JTO | 2023-09-21 |
| 00810144911250 | Northeast Laboratory Services | Northeast Laboratory Services, Inc. | JTO | 2023-09-21 |
| 00810144911267 | Northeast Laboratory Services | Northeast Laboratory Services, Inc. | JTO | 2023-09-21 |
| 00810144911274 | Northeast Laboratory Services | Northeast Laboratory Services, Inc. | JTO | 2023-09-21 |
| 00810144911281 | Northeast Laboratory Services | Northeast Laboratory Services, Inc. | JTO | 2023-09-21 |
| 00816576029129 | HardyDisk™ | HARDY DIAGNOSTICS | JTO | 2023-04-26 |
| 00848838023156 | REMEL | REMEL, INC. | JTO | 2023-01-03 |
| 00848838023194 | REMEL | REMEL, INC. | JTO | 2023-01-03 |
| 00848838023200 | REMEL | REMEL, INC. | JTO | 2023-01-03 |
| 00848838023385 | REMEL | REMEL, INC. | JTO | 2023-01-03 |
| 00848838023392 | REMEL | REMEL, INC. | JTO | 2023-01-03 |
| 00848838072529 | RapID | REMEL, INC. | JTO | 2022-12-23 |
| 00848838023729 | REMEL | REMEL, INC. | JTO | 2022-12-23 |
| 00819398020930 | N/A | HARDY DIAGNOSTICS | JTO | 2022-12-07 |
| 05032384007189 | AN-IDENT DISCSDD6 6X50 DISCS | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034055 | X FACTOR | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034079 | V FACTOR | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034109 | X & V FACTOR | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034130 | METRONIDAZOLE 50 DD8 | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034147 | SUL SULPHONAMIDE | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034154 | ONPG DISCS DD13 | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034178 | O129 DISCS (150µG) | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384034185 | SINGLE CARTRIDGE SPS DISCS DD16 | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384104635 | X FACTOR | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384104659 | V FACTOR | OXOID LIMITED | JTO | 2022-12-04 |
| 05032384105014 | X & V FACTOR | OXOID LIMITED | JTO | 2022-12-04 |
hardydiagnostics.com