ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

FDA premarket approval P090009 · decided 2010-04-29

Approval details

PMA number: P090009
Trade name: ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Applicant: Roche Diagnostics Corp.
Date received: 2009-05-15
Decision date: 2010-04-29
Days to decision: 349 days
Decision code: APRL
Product code: MZO
Advisory committee: Microbiology
Expedited review: No
Location: Indianapolis, IN
Statement: APPROVAL FOR THE ELECSYSANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV ASSAY FOR USE ON MODULAR ANALYTICS E170 ANALYZER. THIS DEVICE IS INDICATED FOR:ELECSYS ANTI-HCV IMMUNOASSAYTHE ROCHE ELECSYS ANTI-HCV ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITHOTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE

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