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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP090007
Date Received05/15/2009
Decision Date04/29/2010
Reclassified Date 12/22/2021
Product Code MZO 
Docket Number 10M-0261
Notice Date 06/14/2010
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYSANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV ASSAY FOR USE ON COBAS E 411IMMUNOASSAY 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 USED TO AID IN THE PRESUMPTIVEDIAGNOSIS 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 COBAS E411 IMMUNOASSAY ANALYZER.ELECSYS PRECICONTROL ANTI-HCVELECSYS PRECICONTROL ANTI-HCV IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HCV IMMUNOASSAY ON THE COBAS E 411 IMMUNOASSAY ANALYZER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S002 S003 S004 S005 S013 S014 S011 S001 S012 S010 S006 S007 
S008 S015 S019 S016 S017 S020  
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