Identity
- Trade Name
- PolyDetector Peroxidase Blocker FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- The PolyDetector Peroxidase Block is a peroxidase free solution used to block the endogenous peroxidase enzymes and transition metals that naturally occur in paraffin embedded tissues, cryostat sections, blood smears, cytosmears, and cell preparations FDA UDI
- Model / Reference
- 200 ml FDA UDI
- Description
- The PolyDetector Peroxidase Block is a peroxidase free solution used to block the endogenous peroxidase enzymes and transition metals that naturally occur in paraffin embedded tissues, cryostat sections, blood smears, cytosmears, and cell preparations FDA UDI
Identifiers
- Catalog Number
- BSB 0053 FDA UDI
- Primary DI / UDI-DI
- B502BSB00530 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
PolyDetector Peroxidase Blocker by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 07bf6dd0-6217-4d02-9d41-b7bc0017e282 34 fields · synced Jun 8, 2026