Data / Medical devices / Test, Carbohydrate Deficient Transferrin
Test, Carbohydrate Deficient Transferrin (NAO): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Test, Carbohydrate Deficient Transferrin (product code NAO, Class 1, 21 CFR 862.1360). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on August 25, 2006, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NAO
- Device class
- 1
- Regulation
- 862.1360
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| Germany | 1 |
| China | 1 |
| France | 1 |
Makers of Test, Carbohydrate Deficient Transferrin
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 1 | August 25, 2006 | 0 | 0 | 0 | api.fda.gov |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sebia | EVRY Essonne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 25, 2006. 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.