Data / Medical devices / System, Test, Tumor Marker, For Detection Of Bladder Cancer
System, Test, Tumor Marker, For Detection Of Bladder Cancer (NAH): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make System, Test, Tumor Marker, For Detection Of Bladder Cancer (product code NAH, Class 3). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NAH
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of System, Test, Tumor Marker, For Detection Of Bladder Cancer
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer | 0 | 1 | 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 | |
| Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC. | Cortlandt Manor, NY, United States | Manufacturer for export | 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.