Identity
- Trade Name
- INFINITI® Warfarin Intellipac® Reagent Module FDA UDI
- Generic Name
- Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system FDA UDI
- Model / Reference
- 03-2140-01 FDA UDI
- Description
- CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system FDA UDI
Identifiers
- Catalog Number
- 03-2140-01 FDA UDI
- Primary DI / UDI-DI
- 00850009370174 FDA UDI
- FDA Product Code
- ODW FDA UDIODV FDA UDI
- GMDN Term
- Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3360 FDA UDI864.7750 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® Warfarin 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 a8379e16-e607-44cd-a791-05c0405dd4da 37 fields · synced Jun 8, 2026