Data / Medical devices / Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment (NSF): 6 FDA-registered makers in 2 countries
6 establishments in 2 countries are registered with the FDA to make Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment (product code NSF, Class 2, 21 CFR 866.6030). 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 February 23, 2011, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NSF
- Device class
- 2
- Regulation
- 866.6030
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| Japan | 3 |
| United States | 3 |
Makers of Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
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 | 1 | February 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) | Amagasaki-shi Hyogo, Japan | Specification developer | 1 | February 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 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 | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 23, 2011. 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.