N/A
- Primary DI
- 00819398028639
- Brand
- N/A
- Company
- HARDY DIAGNOSTICS
- Model
- Z175
- Catalog number
- Z175
- Device description
- PYR Test Kit, 100 tests, with 20ml chromogenic developer, on paper disks A rapid test for Group A Strep and Enterococcus, both of which are PYR positive, all other streps are negative. A more reliable test for Group A Strep than bacitracin, the L-pyrrolidonyl -B-napthylamide impregnated disks serve as a substrate for the detection of pyrrolidonyl peptidase. Contains: PYR Test Disks (100) 00819398027038 PYR Test Disk Vial (1) 10819398027035 PYR Chromagenic Solution 20mL (1) 00819398028622
- 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
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 |
|---|
| 00819398028639 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00819398028639 | 00819398028639 | 819398028639 | 0819398028639 |
GMDN Terms
| Term | Definition |
|---|
| Pyrrolidonyl arylamidase (PYR) activity IVD, kit, colorimetric, rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of pyrrolidonyl arylamidase (PYR) activity in a clinical specimen and/or culture isolate within a short period, relative to standard laboratory testing procedures, using a colorimetric method. It is typically used to differentiate Group A streptococci and enterococci from Group D streptococci. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
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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