Data / Medical devices / Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System (PQP): 13 FDA-registered makers in 1 country
13 establishments in 1 country are registered with the FDA to make Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System (product code PQP, Class 3). 12 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PQP
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
Makers of Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Foundation Medicine, Inc. | Cambridge, MA, United States | Complaint file establishment, Manufacturer | 0 | 4 | 9 | 0 | api.fda.gov | |
| Foundation Medicine, Inc. | Boston, MA, United States | Complaint file establishment, Specification developer | 0 | 4 | 0 | 0 | api.fda.gov | |
| GUARDANT HEALTH, INC (Campus) | Redwood City, CA, United States | Complaint file establishment, Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Carlsbad, CA, United States | Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Frederick, MD, United States | Manufacturer | 0 | 2 | 3 | 0 | api.fda.gov | |
| Caris MPI, Inc | Phoenix, AZ, United States | Complaint file establishment, Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Illumina, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | S San Fran, CA, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Natera Inc. | San Carlos, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Personal Genome Diagnostics Inc. | Baltimore, MD, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Pillar Biosciences | Natick, MA, United States | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| TEMPUS AI, Inc. | Chicago, IL, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Myriad Genetic Laboratories, Inc. | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.