Identity
- Trade Name
- Factor VIII-R Ag. Rabbit Polyclonal Antibody FDA UDI
- Generic Name
- Coagulation factor VIII-associated antigen IVD, antibody FDA UDI
- Model / Reference
- 250A-18 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683130499 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Coagulation factor VIII-associated antigen 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation factor VIII-associated antigen IVD, antibody
Factor VIII-R Ag. Rabbit Polyclonal Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor VIII-associated antigen IVD, antibody.
- FLEX Poly Rb A-Hu Von Willebrand Factor RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- FLEX Poly Rb A-Hu Von Willebrand Factor RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Poly Rb A-Hu Von Willebrand Factor — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Poly Rb A-Hu Von Willebrand Factor — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (1)
- FDA UDI bd65490e-3d4e-4c58-aecf-15f876274adb 33 fields · synced May 31, 2026