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Mouse/Rabbit PolyDetector DAB HRP Brown Detection System
FDA UDIClass I (US FDA UDI)
by Bio Sb, Inc.
Identity
- Trade Name
- Mouse/Rabbit PolyDetector DAB HRP Brown Detection System FDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Mouse/Rabbit PolyDetector DAB HRP Brown System is a one-step polymeric detection system that allows for the demonstration of antigens in formalin-fixed paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations. FDA UDI
- Model / Reference
- 200 ml each FDA UDI
- Description
- Mouse/Rabbit PolyDetector DAB HRP Brown System is a one-step polymeric detection system that allows for the demonstration of antigens in formalin-fixed paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations. FDA UDI
Identifiers
- Catalog Number
- BSB 0207 FDA UDI
- Primary DI / UDI-DI
- B502BSB02070 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
Yes
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 chromogenic substrate IVD, kit, enzyme immunohistochemistry
Mouse/Rabbit PolyDetector DAB HRP Brown Detection System 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 05df1869-02b5-4c7b-a33f-dce380af56be 34 fields · synced May 30, 2026