MYRIAD GENETIC LABORATORIES, INC.

FDA Device Registration & Listing · Salt Lake City, UT, US · Registration 3030654068

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030654068
FEI Number
3030654068
Entity Name
MYRIAD GENETIC LABORATORIES, INC.
City/State/Country
Salt Lake City, UT, US
Establishment Address
322 N 2200 W, Salt Lake City, UT 84116, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Myriad Genetic Laboratories, Inc. (Owner Number: 10048417)
Owner / Operator Contact Address
320 Wakara Way, Salt Lake City, UT 84108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P140020

All Registered Proprietary Names

myChoice CDx BRACAnalysis CDx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown Class 3 N/A 2021-03-03
PJG Cancer-Related Germline Gene Mutation Detection System Unknown Class 3 N/A 2021-03-03
PJG Cancer-Related Germline Gene Mutation Detection System Unknown Class 3 N/A 2015-01-12

Official Correspondent

Rebekah Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Myriad Genetic Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030654068. Last updated year: 2026. Please use registration number 3030654068 when referencing this establishment in official correspondence.
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