Data / Medical devices / Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma (OAU): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma (product code OAU, Class 2, 21 CFR 866.6030). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 31, 2007, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OAU
- Device class
- 2
- Regulation
- 866.6030
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| Japan | 3 |
Makers of Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
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 |
|---|---|---|---|---|---|---|---|---|
| FUJIFILM Healthcare Manufacturing Corporation MIE Office | Komono-cho, Mie-gun, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office | MINAMIASHIGARA-SHI Kanagawa, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) | Amagasaki-shi Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 31, 2007. 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.