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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 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 NumberS005
Date Received02/02/2005
Decision Date02/11/2005
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of raw material specification.
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