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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.
 
DeviceCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP050028
Supplement NumberS017
Date Received03/08/2011
Decision Date07/07/2011
Reclassified Date10/20/2025
Product Code MKT 
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO IN-PROCESS TESTING PROCEDURES FOR THE ELUTION BUFFER AND MANGANESE REAGENT TO BE IMPLEMENTED AT THE MANUFACTURING SITE IN SOMERVILLE, NEW JERSEY.
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