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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 GENOTYPE II
Generic Nameassay, genotyping, hepatitis c virus
Regulation Number866.3170
ApplicantABBOTT MOLECULAR
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP120012
Supplement NumberS010
Date Received12/16/2015
Decision Date03/07/2016
Reclassified Date 12/22/2021
Product Code OBF 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revisions to the application specification file for changes to the liquid level sense and pipette aspiration/dispense volumes during the sample preparation extraction process.
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