Identity
- Trade Name
- AutoDELFIA hCG kit FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG). FDA UDI
- Model / Reference
- B007-112 FDA UDI
- Description
- Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG). FDA UDI
Identifiers
- Catalog Number
- B007-112 FDA UDI
- Primary DI / UDI-DI
- 06438147009343 FDA UDI
- FDA Product Code
- JHJ FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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 hCG kit by Wallac, 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
- Wallac, Inc.
Sources (1)
- FDA UDI 8b86f2b6-31d7-4f45-b0de-d6b0cc6f4605 35 fields · synced May 30, 2026