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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP090009
Date Received05/15/2009
Decision Date04/29/2010
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 10M-0264
Notice Date 06/14/2010
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 immunoassay & elecsys precicontrol anti-hcv assay for use on modular analytics e170 analyzer. This device is indicated for: elecsys anti-hcv immunoassay the roche elecsys anti-hcv assay is an in vitro diagnostic test for the qualitative detection 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 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 electrochemilumi-nescence immunoassay "eclia" is intended for use on the modular analytics e170 immunoassay analyzer.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S010 S011 
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