Identity
- Trade Name
- VisuLize Factor FVIII Antigen Kit FDA UDI
- Generic Name
- Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 96 Test enzyme immunoassay kit for the determination of FVIII Antigen FDA UDI
- Model / Reference
- FVIII-AG FDA UDI
- Description
- 96 Test enzyme immunoassay kit for the determination of FVIII Antigen FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10629009010000 FDA UDI
- 510(k) Number
- K052825 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
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 IVD, kit, enzyme immunoassay (EIA)
VisuLize Factor FVIII Antigen Kit by Affinity Biologicals Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Affinity Biologicals Inc
Sources (1)
- FDA UDI 8ecc3de6-1c41-4f21-89a6-db5099740ed3 36 fields · synced Jun 8, 2026