|
Device | COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P050028 |
Supplement Number | S015 |
Date Received | 03/01/2011 |
Decision Date | 07/12/2012 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS OF BULK CAPG GNR WASH REAGENT. |