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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 NameVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameanti-hcv assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP010021
Date Received04/02/2001
Decision Date08/30/2001
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 01M-0536
Notice Date 12/05/2001
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 vitros immunodiagnostic products anti-hcv reagent pack and vitros immunodiagnostic products anti-hcv calibrator. These devices are indicated for: the vitros immunodiagnostic products anti-hcv reagent pack is indicated 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 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. The vitros immunodiagnostic products anti-hcv calibrator is indicated for use in the calibration of the vitros eci immunodiagnostic system 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 vitros anti-hcv reagent packs. The vitros anti-hcv calibrator has been validated for use only on the vitros eci immunodiagnostic system with the vitros immunodiagnostic products anti-hcv reagent pack.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 
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