Data / Medical devices / System, Immunomagnetic, Circulating Cancer Cell, Enumeration
System, Immunomagnetic, Circulating Cancer Cell, Enumeration (NQI): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make System, Immunomagnetic, Circulating Cancer Cell, Enumeration (product code NQI, Class 2, 21 CFR 866.6020). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on June 20, 2013, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NQI
- Device class
- 2
- Regulation
- 866.6020
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of System, Immunomagnetic, Circulating Cancer Cell, Enumeration
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 |
|---|---|---|---|---|---|---|---|---|
| Menarini Silicon Biosystems Inc. | Huntingdon Valley, PA, United States | Manufacturer, Specification developer | 3 | June 20, 2013 | 0 | 2 | 0 | api.fda.gov |
| Sigma-Aldrich Manufacturing, LLC | St. Louis, MO, United States | Contract manufacturer, Repackager or relabeler | 1 | December 21, 2010 | 0 | 0 | 0 | api.fda.gov |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 20, 2013. 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.