|
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 | S041 |
Date Received | 05/18/2021 |
Decision Date | 06/02/2021 |
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 an update to the hazard information on the product labeling for kits on the cobas 6800/8800 Systems. |