Identity
- Trade Name
- INFINITI® Factor II Intellipac® Reagent Module FDA UDI
- Generic Name
- Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Genotyping system for the detection of Factor II (Prothrombin) G20210A mutation FDA UDI
- Model / Reference
- 01-2020-01 FDA UDI
- Description
- Genotyping system for the detection of Factor II (Prothrombin) G20210A mutation FDA UDI
Identifiers
- Catalog Number
- 01-2020-01 FDA UDI
- Primary DI / UDI-DI
- 00850009370051 FDA UDI
- FDA Product Code
- NPR FDA UDINSU 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 UDI862.2570 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
INFINITI® Factor II Intellipac® Reagent Module by Autogenomics, 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
- Autogenomics, Inc
Sources (1)
- FDA UDI e5f55ae5-3380-4402-8694-eaf995975f67 37 fields · synced May 30, 2026