HardyDisk™
- Primary DI
- 00816576028443
- Brand
- HardyDisk™
- Company
- HARDY DIAGNOSTICS
- Model
- Z7191
- Catalog number
- Z7191
- Device description
- Kanamycin, 1000mcg, differentiates anaerobic bacteria on the basis of susceptibility to kanamycin, 1 x 50 disks, for ID of anaerobes Differentiates anaerobic bacteria on the basis of susceptibility to kanamycin.
- Published
- 2020-08-10
- 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 |
|---|
| 00816576028450 | Primary | GS1 | 0 | |
| 00816576028443 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00816576028450 | 00816576028450 | 816576028450 | 0816576028450 |
| 00816576028443 | 00816576028443 | 816576028443 | 0816576028443 |
GMDN Terms
| Term | Definition |
|---|
| Antibacterial susceptibility testing disc IVD | A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method. |
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
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|---|
| 00848838059865 | ^BM^ PK/50 OXIDASE TEST | REMEL, INC. | JTO | 2026-01-16 |
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| 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 |
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| 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 |
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