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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 INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY
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 NumberS021
Date Received10/05/2011
Decision Date11/10/2011
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
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