Data / Medical devices / Next Generation Sequencing Based Tumor Profiling Test
Next Generation Sequencing Based Tumor Profiling Test (PZM): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Next Generation Sequencing Based Tumor Profiling Test (product code PZM, Class 2, 21 CFR 866.6080). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on May 12, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PZM
- Device class
- 2
- Regulation
- 866.6080
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| India | 1 |
| Canada | 1 |
| China | 1 |
Makers of Next Generation Sequencing Based Tumor Profiling Test
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 |
|---|---|---|---|---|---|---|---|---|
| Datar Cancer Genetics Private Limited | Nasik Maharashtra, India | Manufacturer | 1 | May 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Geneseeq Technology Inc. | Toronto Ontario, Canada | Specification developer | 1 | August 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Personal Genome Diagnostics Inc. | Baltimore, MD, United States | Manufacturer | 1 | April 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| TEMPUS AI, Inc. | Chicago, IL, United States | Manufacturer | 1 | September 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Geneseeq Medical Device And Diagnostic Inc. | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Frederick, MD, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 12, 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.