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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.
 
DeviceABBOTT REALTIME HCV
Generic Nameassay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP100017
Supplement NumberS007
Date Received07/23/2013
Decision Date08/20/2013
Reclassified Date 12/22/2021
Product Code MZP 
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING PROCESS FOR OLIGONUCLEOTIDES AND THE ADDITION OF TWO NEW SUPPLIERS FOR A RAW MATERIAL.
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