|
Device | THXID-BRAF KIT |
Generic Name | Somatic gene mutation detection system |
Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
PMA Number | P120014 |
Supplement Number | S001 |
Date Received | 10/10/2014 |
Decision Date | 01/30/2015 |
Withdrawal Date
|
06/24/2024 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW DETERMINATION METHOD OF PLASMIDS AND TRANSCRIPTS CONCENTRATION DURING THE MANUFACTURING STEP (FGM/POL/ M00454), BY USING NANODROP UV-VIS SPECTROPHOTOMETER TO CHANGE FROM THE OLD METHOD UTILIZING STANDARD UV-VIS SPECTROPHOTOMETER. |