Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Alinity i Anti-HBc Reagent Kit 200 Tests FDA UDI
- Model / Reference
- 07P8421 FDA UDI
- Description
- Alinity i Anti-HBc Reagent Kit 200 Tests FDA UDI
Identifiers
- Catalog Number
- 07P8421 FDA UDI
- Primary DI / UDI-DI
- 00380740136659 FDA UDI
- PMA Number
- P080023 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
- 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
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
Category: Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Alinity by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica IM HBcT — Siemens Healthcare Diagnostics · Class II
- LIAISON® XL MUREX Anti-HBc — Diasorin Inc.
- Atellica IM HBcT2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys Anti-HBc II — Roche Diagnostics Corp. · Class II
- Atellica IM HBcT2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® 2000 Systems aBC Anti-HBc — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA UDI d47a0604-5e1b-47e1-8050-681f5fb8ffcd 37 fields · synced May 30, 2026