|
Device | cobas HBV |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P150014 |
Supplement Number | S039 |
Date Received | 09/17/2020 |
Decision Date | 10/07/2020 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes being effected to update hazard labeling. |