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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 NumberS013
Date Received03/20/2008
Decision Date04/16/2008
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the modification to interface the automated vitros analyzer using the robotic interface module (rim) to enable automatic tray loading between the vitros analyzer and engen system.
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