N/A
- Primary DI
- 00819398025751
- Brand
- N/A
- Company
- HARDY DIAGNOSTICS
- Model
- Y321
- Catalog number
- Y321
- Device description
- Phenol Red Broth with Glucoside, 10ml fill, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
- Published
- 2020-06-09
- 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 |
|---|
| JSF | Culture Media, Single Biochemical Test |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JSF | Culture Media, Single Biochemical Test | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00819398025768 | Primary | GS1 | 0 | |
| 00819398025751 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00819398025768 | 00819398025768 | 819398025768 | 0819398025768 |
| 00819398025751 | 00819398025751 | 819398025751 | 0819398025751 |
GMDN Terms
| Term | Definition |
|---|
| Differential/selective broth culture medium IVD | A broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 039981550
- Device count
- 20
- 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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| 00848838007545 | REMEL | REMEL, INC. | JSF | 2022-12-23 |
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| 00819398026550 | N/A | HARDY DIAGNOSTICS | JSF | 2020-08-07 |
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