Identity
- Trade Name
- Elecsys HBsAg II FDA UDI
- Generic Name
- Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 08814864160 FDA UDI
Identifiers
- Catalog Number
- 08814864160 FDA UDI
- Primary DI / UDI-DI
- 07613336198278 FDA UDI
- PMA Number
- P160019 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus surface antigen 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
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
Elecsys HBsAg II by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P160019 also covers:
- Elecsys HBsAg Confirmatory Test — Roche Diagnostics Corp.
- Elecsys HBsAg II — Roche Diagnostics Corp.
- Elecsys HBsAg II — Roche Diagnostics Corp.
- Elecsys HBsAg II Auto Confirm — Roche Diagnostics Corp.
- PreciControl HBsAg Auto Confirm — Roche Diagnostics Corp.
- PreciControl HBsAg II — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 1fcd69fa-c62d-49c3-a08c-ea10baa307e9 36 fields · synced May 30, 2026