Identity
- Trade Name
- Alinity m HCV FDA PMA
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3170 FDA PMA
- Regulation Number
- 866.3170 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- SESE Substantially Equivalent FDA PMA
The Alinity m HCV is an Assay, Hybridization and/or Nucleic Acid Amplification for Detection of Hepatitis C RNA, Hepatitis C Virus, classified under Class II (device class 2) in microbiology. It is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay designed to detect and quantify hepatitis C virus (HCV) RNA in human plasma (EDTA or Acid Citrate Dextrose) or serum from HCV antibody-positive individuals. The assay aids in diagnosing active HCV infection in antibody-positive patients and supports the management of known active infections, including sustained virologic response (SVR) determination.
The Alinity m HCV is intended for laboratory use only and is not approved for screening blood, plasma, serum, tissue, or tissue donors. Supplied as a single-use reagent system, it requires compliance with standard molecular laboratory protocols. The device holds FDA_510K and FDA_PMA authorizations, with clearance under the Microbiology advisory committee. Storage and handling follow manufacturer guidelines for nucleic acid amplification assays, ensuring sterility and performance integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Alinity | Core Laboratory bei Abbott, Alinity | Core Laboratory at Abbott, Alinity n - transfusion.abbott
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252102 | Class II | Active |
| FDA PMA | United States | FDA_PMA | P190025 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (2)
- FDA PMA P190025 37 fields · synced Sep 18, 2026
- FDA 510(k) K252102 1 fields · synced May 18, 2026