Myriad-Genetic-Laboratories

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3030654068	3030654068	MYRIAD GENETIC LABORATORIES, INC.	1	N	2026-01-01	322 N 2200 W Salt Lake City UT US 84116
3003034728	3003034728	MYRIAD GENETIC LABORATORIES, INC.	1	N	2020-04-25	320 Wakara Way Salt Lake City UT US 84108

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
330029	1931400495	P190014	myChoice HRD CDx	PJG	2019-10-23
179141	1841492350	P140020	BRACANALYSIS CDX	PJG	2014-12-19
330029	1841492350	P140020	BRACANALYSIS CDX	PJG	2014-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PJG	3	2019-10-23

PMA#

BRACAnalysis CDx®
2023-01-27
MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS026 Date Received01/11/2023 Decision Date01/27/2023 Product Code PJG Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process C...
BRACAnalysis CDx®
2022-11-16
MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS025 Date Received10/18/2022 Decision Date11/16/2022 Product Code PJG Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reas...
MyChoice CDx®
2022-11-14
Myriad Genetic Laboratories, Inc320 Wankara Waysalt Lake City, UT 84108 PMA NumberP190014 Supplement NumberS007 Date Received10/17/2022 Decision Date11/14/2022 Product Code PJG Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplemen...
BRACAnalysis CDx®
2022-11-10
MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS024 Date Received10/14/2022 Decision Date11/10/2022 Product Code PJG Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process C...
BRACAnalysis CDx®
2022-03-11
MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS022 Date Received10/22/2021 Decision Date03/11/2022 Product Code PJG Advisory Committee Pathology Clinical TrialsNCT02032823 Supplement Typenormal 180 Day...
myChoice CDx
2022-02-10
Myriad Genetic Laboratories, Inc
BRACAnalysis CDx
2021-07-02
MYRIAD GENETIC LABORATORIES
myChoice HRD CDx
2021-06-24
Myriad Genetic Laboratories, Inc
myChoice CDx
2021-01-27
Myriad Genetic Laboratories, Inc
BRACAnalysis CDx
2020-05-19
MYRIAD GENETIC LABORATORIES
myChoice CDx
2020-05-08
Myriad Genetic Laboratories, Inc
myChoice CDx
2020-04-29
Myriad Genetic Laboratories, Inc
myChoice CDx
2020-03-23
Myriad Genetic Laboratories, Inc
BRACAnalysis CDx
2019-12-27
MYRIAD GENETIC LABORATORIES
myChoice HRD CDx
2019-10-23
Myriad Genetic Laboratories, Inc
BRACAnalysis CDx
2019-03-06
MYRIAD GENETIC LABORATORIES
BRACAnalysis CDx
2018-12-19
MYRIAD GENETIC LABORATORIES
BRACAnalysis CDx
2018-10-25
MYRIAD GENETIC LABORATORIES
BRACAnalysis CDx
2018-10-16
MYRIAD GENETIC LABORATORIES
BRACAnalysis CDx device
2018-10-16
MYRIAD GENETIC LABORATORIES
BRACAnalysis CDx
2018-01-12
MYRIAD GENETIC LABORATORIES
BRACAnalysis CDx
2017-10-26
MYRIAD GENETIC LABORATORIES
BRACAnalysis CDx
2017-03-27
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX
2017-01-30
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX
2016-07-26
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX
2016-06-17
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDx
2016-06-17
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX
2016-04-29
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX DEVICE
2016-02-18
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX
2015-12-22
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX
2015-11-18
MYRIAD GENETIC LABORATORIES
BRACANALYSIS CDX
2014-12-19
MYRIAD GENETIC LABORATORIES