|
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 | S004 |
Date Received | 03/03/2015 |
Decision Date | 04/01/2015 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF A QUALITY CONTROL TEST FOR THE THXID¿-BRAF MASTERMIX. |