|
Device | COBAS TaqMan HBV Test / High Pure System Viral Nucleic Acid Kit |
Generic Name | hepatitis viral b dna detection |
Applicant |
Roche Molecular Systems, Inc. |
4300 hacienda drive |
pleasanton, CA 94588-2722 |
|
PMA Number | P050028 |
Supplement Number | S058 |
Date Received | 09/26/2017 |
Decision Date | 10/13/2017 |
Product Code |
MKT
|
Advisory Committee |
Microbiology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Use larger columns for purification steps in probe manufacturing. |