Identity
- Trade Name
- Factor II Prothrombin G20210A Kit FDA UDI
- Generic Name
- Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 04618955001 FDA UDI
- Primary DI / UDI-DI
- 04038377021591 FDA UDI
- FDA Product Code
- NPR FDA UDI
- GMDN Term
- Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7280 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
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 II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)
Factor II Prothrombin G20210A Kit by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT).
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 8e7b6552-2492-4a33-b175-994ccf117ba4 33 fields · synced Jun 6, 2026