Data / Medical devices / Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Alpha-1-Lipoprotein, Antigen, Antiserum, Control (DER): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Alpha-1-Lipoprotein, Antigen, Antiserum, Control (product code DER, Class 2, 21 CFR 866.5580). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on November 16, 2001, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DER
- Device class
- 2
- Regulation
- 866.5580
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 2 |
| Japan | 1 |
| Switzerland | 1 |
Makers of Alpha-1-Lipoprotein, Antigen, Antiserum, Control
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 |
|---|---|---|---|---|---|---|---|---|
| Kamiya Biomedical Company LLC | Tukwila, WA, United States | Manufacturer | 2 | October 28, 1999 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | January 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Contract manufacturer, Manufacturer | 1 | January 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | November 16, 2001 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 16, 2001. 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.