|
Device | COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS 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 | S023 |
Date Received | 10/22/2015 |
Decision Date | 05/20/2016 |
Product Code |
PAB |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for use with hematopoietic stem-cell transplant patients and to increase the whole blood stability claim in the Package Insert. |