|
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 | S011 |
Date Received | 09/22/2010 |
Decision Date | 06/24/2011 |
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 AN ADDITION OF A SECOND SINTERING OVEN FOR THE MANUFACTURE OF THE BULK MAGNETIC GLASS PARTICLE (MGP) RAW MATERIAL USED IN THE PRODUCTION OF THE MPG REAGENT. |