PMA P120014S004
- Device
- THXID BRAF KIT
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S004
- Product code
- OWD
- Decision date
- 2015-04-01
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- APPROVAL FOR ADDITION OF A QUALITY CONTROL TEST FOR THE THXID¿-BRAF MASTERMIX.
Current openFDA PMA Record#
- Device
- THXID BRAF KIT
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S004
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-04-01
- Decision code
- APPR
- Date received
- 2015-03-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITION OF A QUALITY CONTROL TEST FOR THE THXID¿-BRAF MASTERMIX.