Identity
- Trade Name
- PAX5 FDA UDI
- Generic Name
- B-cell specific activator protein (BSAP) IVD, antibody FDA UDI
- Model / Reference
- CM207C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627006806 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- B-cell specific activator protein (BSAP) IVD, antibody 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: B-cell specific activator protein (BSAP) IVD, antibody
Pax5 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as B-cell specific activator protein (BSAP) IVD, antibody.
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- PAX-5 (24) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- PAX-5 (EP156) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
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
- Biocare Medical, Llc
Sources (1)
- FDA UDI ff8808a0-665f-4479-a309-bfc4892b73ba 33 fields · synced Jun 8, 2026