Elecsys Anti-HCV II Immunoassay Test System
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FDA PMA
- Generic Name
- Assay, enzyme linked immunosorbent, hepatitis c virus FDA PMA
Identifiers
- PMA Number
- P140021 FDA PMA
- FDA Product Code
- MZO FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3169 FDA PMA
- Regulation Number
- 866.3169 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Elecsys Anti-HCV II Immunoassay Test System is an enzyme-linked immunosorbent assay (ELISA) intended for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. It employs an electrochemiluminescence immunoassay (ECLIA) technology to identify HCV antibodies in adult and pediatric samples aged 18 months through 21 years, aiding in the presumptive diagnosis of HCV infection when used alongside clinical information and other laboratory results.
This system is designed for use on the Roche Cobas E 601 immunoassay analyzer, with the Elecsys PreciControl Anti-HCV serving as a quality control measure for the Elecsys Anti-HCV II Immunoassay on the Cobas E 601 and Cobas E 602 analyzers. Supplied as a reagent kit, the device is intended for laboratory use and requires compliance with standard microbiological practices. Approval for the Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV was granted under an FDA Premarket Approval (PMA) application.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P140021 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Operations, Inc.
Sources (1)
- FDA PMA P140021 24 fields · synced Oct 6, 2026