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HPV MultiDetector HRP/AP Detection System Kit
FDA UDIClass I (US FDA UDI)
by Bio Sb, Inc.
Identity
- Trade Name
- HPV MultiDetector HRP/AP Detection System Kit FDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Ready-to-use, HPV MultiDetector HRP/AP Kit dual stain includes a cocktail of Ki67 and p16 antibodies to form a sensitive and specific test for significant cervical lesions or oral and oropharyngeal SCC. FDA UDI
- Model / Reference
- Ready-to-use, 70 tests each FDA UDI
- Description
- Ready-to-use, HPV MultiDetector HRP/AP Kit dual stain includes a cocktail of Ki67 and p16 antibodies to form a sensitive and specific test for significant cervical lesions or oral and oropharyngeal SCC. FDA UDI
Identifiers
- Catalog Number
- BSB 0354-7 FDA UDI
- Primary DI / UDI-DI
- B502BSB035470 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
HPV MultiDetector HRP/AP Detection System Kit 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 143592a3-84c3-4ee7-bfe2-b8de3f64cdbd 34 fields · synced May 30, 2026