PMA P120014S005
- Device
- THXID BRAF KIT
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S005
- Product code
- OWD
- Decision date
- 2015-06-05
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- CHANGE IN THE METHOD USED TO DETERMINE THE CONCENTRATION OF THE OLIGONUCLEOTIDES AND PROBES USED IN THE TEST KIT.
Current openFDA PMA Record#
- Device
- THXID BRAF KIT
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S005
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-06-05
- Decision code
- OK30
- Date received
- 2015-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE METHOD USED TO DETERMINE THE CONCENTRATION OF THE OLIGONUCLEOTIDES AND PROBES USED IN THE TEST KIT.