Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI
- Device Name
- Alinity i Anti-HCV Reagent Kit 200 Tests FDA UDI
- Model / Reference
- 08P0521 FDA UDI
- Description
- Alinity i Anti-HCV Reagent Kit 200 Tests FDA UDI
Identifiers
- Catalog Number
- 08P0521 FDA UDI
- Primary DI / UDI-DI
- 00380740130657 FDA UDI
- PMA Number
- P050042 FDA UDI
- FDA Product Code
- MZO FDA UDI
- GMDN Term
- Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3169 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 C virus total antibody IVD, kit, chemiluminescent assay
Alinity by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis C virus total antibody IVD, kit, chemiluminescent assay.
- Elecsys Anti-HCV II — Roche Diagnostics Corp. · Class II
- Atellica IM aHCV 200T — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Alinity — Abbott Laboratories, Inc.
- Elecsys Anti-HCV II — Roche Diagnostics Corp. · Class II
- ADVIA Centaur HCV — Siemens Healthcare Diagnostics · Class II
- Elecsys Anti-HCV II — Roche Diagnostics Corp. · 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 |
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Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA UDI ca78dccf-e47b-4b8a-980b-b81b8db99c7b 37 fields · synced Jun 1, 2026