|
Device | cobas AmpliPrep/cobas TaqMan CMV Test |
Generic Name | Cytomegalovirus (cmv) dna quantitative assay |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P110037 |
Supplement Number | S048 |
Date Received | 07/15/2019 |
Decision Date | 08/13/2019 |
Product Code |
PAB |
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 the addition of an instruction to the labeling to visually inspect reagent cassette and vial prior to use. |