Data / Medical devices / Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Immunoelectrophoretic, Immunoglobulins, (G, A, M) (CFF): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Immunoelectrophoretic, Immunoglobulins, (G, A, M) (product code CFF, Class 2, 21 CFR 866.5510). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on November 12, 2021, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CFF
- Device class
- 2
- Regulation
- 866.5510
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| France | 1 |
| United Kingdom | 1 |
| Italy | 1 |
| Japan | 1 |
Makers of Immunoelectrophoretic, Immunoglobulins, (G, A, M)
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 |
|---|---|---|---|---|---|---|---|---|
| Sebia | EVRY Essonne, France | Manufacturer | 10 | November 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 3 | July 6, 2006 | 0 | 2 | 0 | api.fda.gov |
| Kamiya Biomedical Company LLC | Tukwila, WA, United States | Manufacturer | 2 | November 30, 1999 | 0 | 1 | 0 | api.fda.gov |
| Helena Laboratories UK Ltd | Gateshead Newcastle upon Tyne, United Kingdom | Manufacturer | 1 | June 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Interlab S.R.L. | ROME Lazio, Italy | Manufacturer | 1 | October 13, 2011 | 0 | 0 | 0 | api.fda.gov |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 12, 2021. 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.