Identity
- Trade Name
- Elecsys Anti-HBc II FDA UDI
- Generic Name
- Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 09014926162 FDA UDI
Identifiers
- Catalog Number
- 09014926162 FDA UDI
- Primary DI / UDI-DI
- 07613336183106 FDA UDI
- FDA Product Code
- QHM FDA UDI
- GMDN Term
- Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 610.40 FDA UDI
- Commercial Distribution
- 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
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
Category: Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay
Elecsys Anti-HBc II by Roche Diagnostics Corp. — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI b214d8ea-328f-4946-a6d1-d027e11a4796 33 fields · synced Jun 1, 2026