PMA P140020S008

Device: BRACANALYSIS CDX
Applicant: Myriad Genetic Laboratories
PMA number: P140020
Supplement: S008
Product code: PJG
Decision date: 2017-01-30
Classification: Cancer-related Germline Gene Mutation Detection System
Generic name: Cancer-related germline gene mutation detection system
Approval order statement: Approval for the inclusion of the BRACAnalysis CDx - DNA Quantification Technical Manual, the BRACAnalysis CDx - Sanger Technical Manual, and the BRACAnalysis CDX – BART Technical Manual in place of several laboratory Standard Operating Procedures.

Current openFDA PMA Record#

Device: BRACANALYSIS CDX
Applicant: Myriad Genetic Laboratories
PMA number: P140020
Supplement: S008
Product code: PJG
Generic name: Cancer-related germline gene mutation detection system
Decision date: 2017-01-30
Decision code: APPR
Date received: 2016-10-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the inclusion of the BRACAnalysis CDx - DNA Quantification Technical Manual, the BRACAnalysis CDx - Sanger Technical Manual, and the BRACAnalysis CDX – BART Technical Manual in place of several laboratory Standard Operating Procedures.