Data / Medical devices / Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies (QDC): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies (product code QDC, Class 2, 21 CFR 866.6100). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on August 5, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QDC
- Device class
- 2
- Regulation
- 866.6100
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
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 |
|---|---|---|---|---|---|---|---|---|
| Adaptive Biotechnologies | Bothell, WA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 2 | August 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Adaptive Biotechnologies | Seattle, WA, United States | Complaint file establishment, Specification developer | 2 | August 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid | Lodi, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 5, 2020. 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.