Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | COBAS TAQMAN HBV TEST |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P050028 |
Supplement Number | S002 |
Date Received | 10/31/2008 |
Decision Date | 11/25/2008 |
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 REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USE DIN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI). |
|
|