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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 REAL TIME HCV GENOTYPE II
Generic NameAssay, genotyping, hepatitis c virus
Regulation Number866.3170
ApplicantABBOTT MOLECULAR
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP120012
Supplement NumberS004
Date Received08/28/2014
Decision Date09/25/2014
Reclassified Date 12/22/2021
Product Code OBF 
Advisory Committee Microbiology
Clinical TrialsNCT00351403
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MANUFACTURING PROCESS CHANGES AND IN-PROCESS QUALITY CONTROL METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE.
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