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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 IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantOrtho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester, NY 14626
PMA NumberP010021
Supplement NumberS003
Date Received07/16/2004
Decision Date07/30/2004
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING EQUIPMENT AND MANUFACTURING PROCESS STEPS ACCEPTANCE CRITERIA ASSOCIATED WITH THIS EQUIPMENT CHANGE. THE PROPOSED CHANGES AFFECT THE MANUFACTURING OF VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.
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