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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 supplement. The device description may have changed. Be sure to look at the original PMA 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
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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