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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameassay,enzyme linked immunosorbent,hepatitis c virus
Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, NY 14626-5101
PMA NumberP010021
Supplement NumberS007
Date Received09/16/2005
Decision Date01/12/2006
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE REMOVAL OF THE WARNING ASSOCIATED WITH PRENATAL SCREENING AND A MODIFIED INDICATION FOR USE. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR WITH THE ADDITION OF MODEL DESIGNATIONS (ECIQ/ECI), AND IS INDICATED AS FOLLOWS:FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM. THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS, (STATE OR ASSOCIATED DISEASE NOT DETERMINED), IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS C INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HCV DURING THE PRENATAL PERIOD.
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