PMA P140020S005
- Device
- BRACANALYSIS CDX DEVICE
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S005
- Product code
- PJG
- Decision date
- 2016-02-18
- Classification
- Cancer-related Germline Gene Mutation Detection System
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- New polymerase to be used in DNA sequencing process.
Current openFDA PMA Record#
- Device
- BRACANALYSIS CDX DEVICE
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S005
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2016-02-18
- Decision code
- OK30
- Date received
- 2015-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New polymerase to be used in DNA sequencing process.