|
Device | COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/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 | S023 |
Date Received | 12/12/2011 |
Decision Date | 09/18/2012 |
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 THE MANUFACTURING CHANGES TO THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR THE VIALED MASTER MIX AND PROBE REAGENT COMPONENTS. |