|
Device | AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST |
Generic Name | System, nucleic acid amplification, mycobacterium tuberculosis complex |
Regulation Number | 866.3372 |
Applicant | Roche Molecular Systems, Inc. 4300 HACIENDA DR. PLEASANTON, CA 94588-0900 |
PMA Number | P940040 |
Supplement Number | S003 |
Date Received | 04/07/2004 |
Decision Date | 04/22/2004 |
Withdrawal Date
|
09/06/2013 |
Product Code |
MWA |
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 CHANGE TO THE MANUFACTURING PROCESS OF THE DEVICE TO INCORPORATE A TERMINAL 0.2UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS TO ENSURE THE REMOVAL OF ADVENTITIOUS AGENTS REMAINING IN THE REAGENT FOLLOWING FORMULATION. |