|
Device | COBAS AMPLIPREP/COBAS TAQMAN HBV TEST |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P050028 |
Supplement Number | S044 |
Date Received | 02/25/2015 |
Decision Date | 05/01/2015 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE MAGNETIC GLASS PARTICLE (MGP) REAGENT BOTTLES AND CLOSURES. |