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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameelecsys anti-hcv ii immunoassay; anti-hcv ii, elecsys precicontrol anti-hcv, precicontrol anti-hcv
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
PMA NumberP140021
Date Received10/17/2014
Decision Date06/11/2015
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 15M-2217
Notice Date 07/10/2015
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the elecsys anti-hcv ii immunoassay and elecsys precicontrol anti-hcv. This device is indicated for: elecsys anti-hcv ii immunoassay immunoassay for the in vitro qualitative detection of antibodies to hepatitis c virus (hcv) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium edta, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hcv infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. The test does not determine the state of infection or associated disease. The electroluminescence immunoassay eclia is intended for use on the roche cobas e 601 immunoassay analyzer. Elecsys precicontrol anti-hcv elecsys precicontrol anti-hcv is used for quality control of the elecsys anti-hcv immunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers and the elecsys anti-hcv ii immunoassay on the cobas e 601 immunoassay analyzer.
Approval Order Approval Order
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