Identity
- Trade Name
- AutoDELFIA hAFP Kit FDA UDI
- Generic Name
- Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP) FDA UDI
- Model / Reference
- B079-201 FDA UDI
- Description
- Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP) FDA UDI
Identifiers
- Catalog Number
- B079-201 FDA UDI
- Primary DI / UDI-DI
- 06438147321315 FDA UDI
- PMA Number
- P970037 FDA UDI
- FDA Product Code
- LOK FDA UDI
- GMDN Term
- Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
AutoDELFIA hAFP Kit by Wallac, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P970037 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (1)
- FDA UDI 274039f8-e811-4900-85c7-1fb653256ce3 37 fields · synced May 30, 2026