N/A
- Primary DI
- 00819398028592
- Brand
- N/A
- Company
- HARDY DIAGNOSTICS
- Model
- Z120
- Catalog number
- Z120
- Device description
- C. diff PRO, a rapid proline and indole test for Clostridioides difficile, 25 test cards, 1 reagent, 16oz jar C. diff PRO™ Test Kit is recommended for use in screening suspected Clostridioides difficile isolates for L-proline aminopeptidase activity and a lack of indole activity. The test performs a proline separately from indole for a clear test interpretation. Developing Reagent (1) 00819398028585 C. diff PRO Card (25) 00819398027113
- Published
- 2020-08-06
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00819398028592 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00819398028592 | 00819398028592 | 819398028592 | 0819398028592 |
GMDN Terms
| Term | Definition |
|---|---|
| Chromogenic substrate reagent IVD | A reagent or solution that gives off colour in a biochemical reaction, intended to be used in combination with other IVDs in the testing of a clinical specimen, typically using an enzyme immunoassay method. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 039981550
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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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| 00819398023603 | N/A | R76BX | R76BX | 2020-06-05 |
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| 00819398027199 | N/A | Z134 | Z134 | 2020-06-10 |
| 00819398027779 | N/A | Z135 | Z135 | 2020-06-10 |
| 00816576023516 | N/A | 1020 | 1020 | 2020-05-26 |
| 00816576025800 | TransPRO | TPV50 | TPV50 | 2024-10-08 |
| 00816576026951 | N/A | G367 | G367 | 2024-07-08 |
| 00816576026586 | N/A | J139 | J139 | 2020-05-20 |
| 00816576026876 | N/A | R12 | R12 | 2024-03-08 |
| 00819398021593 | N/A | R63BX | R63BX | 2024-01-15 |
| 00819398020602 | N/A | K02 | K02 | 2020-05-24 |
| 00816576026838 | HardyCHROM™ | J28 | J28 | 2023-12-08 |
| 00816576024391 | AnaeroGRO | AG051 | AG051 | 2020-05-12 |
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