PolyDetector HRP Black kit
- Primary DI
- B502BSB00890
- Brand
- PolyDetector HRP Black kit
- Company
- BIO SB, INC.
- Model
- 1000 Tests
- Catalog number
- BSB 0089
- Device description
- PolyDetector HRP Black Substrate-Chromogen used with peroxidase detection systems for demonstration of cell antigens or nucleic acids in paraffin embedded tissues, cryostat sections, cytosmears, and cell preparations
- Published
- 2020-08-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B502BSB00890 | Primary | HIBCC | 0 | |
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. |
Regulatory Flags
- DUNS number
- 102855447
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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