Identity
- Trade Name
- IMMULITE®/IMMULITE®1000 Systems aBC Anti-HBc FDA UDI
- Generic Name
- Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- aBC Anti-HBc Kit 100 Test FDA UDI
- Model / Reference
- 10370305 FDA UDI
- Description
- aBC Anti-HBc Kit 100 Test FDA UDI
Identifiers
- Catalog Number
- LKHC1(D) FDA UDI
- Primary DI / UDI-DI
- 00630414970974 FDA UDI
- PMA Number
- P010051 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3172 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
No
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
IMMULITE®/IMMULITE®1000 Systems aBC Anti-HBc by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
P010051 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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI f5b7618c-a883-4a8f-898e-03399a626f9e 38 fields · synced May 30, 2026