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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 Amplification Reagent Kit / HCV Genotype II Control Kit
Generic Nameassay, genotyping, hepatitis c virus
Regulation Number866.3170
ApplicantABBOTT MOLECULAR
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP120012
Supplement NumberS016
Date Received06/27/2017
Decision Date09/01/2017
Reclassified Date 12/22/2021
Product Code OBF 
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly.
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