Data / Medical devices / United States / Myriad Genetic Laboratories, Inc.
Myriad Genetic Laboratories, Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 2 PMA approvals
Myriad Genetic Laboratories, Inc. is registered with the FDA (registration 3030654068) in Salt Lake City, UT, United States. It lists 2 device types. The FDA files 2 PMA approvals under its listings, the newest dated October 23, 2019. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030654068
- Address
- 322 N 2200 W, Salt Lake City, UT, United States, 84116
- Owner or operator
- Myriad Genetic Laboratories, Inc. (10048417)
- Roles
- Manufacturer
- First device listed
- January 12, 2015
- Registered through
- 2027
- Brand names listed
- BRACAnalysis CDx, myChoice CDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cancer-Related Germline Gene Mutation Detection System | PJG | 3 | Manufacturer | accessdata.fda.gov |
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 23, 2019 | P190014 | myChoice HRD CDx | PJG | 11 | March 10, 2026 | accessdata.fda.gov |
| December 19, 2014 | P140020 | BRACANALYSIS CDX | PJG | 25 | October 4, 2024 | accessdata.fda.gov |
Compare with other makers
Updated March 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.