|
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 | S043 |
Date Received | 12/19/2014 |
Decision Date | 01/14/2015 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement RELOCATION OF INSTRUMENTS USED FOR FUNCTIONAL TESTING OF COMPONENTS AND FINISHED DEVICES TO A NEW LABORATORY WITHIN THE SAME MANUFACTURING FACILITY AT PENZBERG, GERMANY. |