Data / Medical devices / Igm, Antigen, Antiserum, Control
Igm, Antigen, Antiserum, Control (DFT): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Igm, Antigen, Antiserum, Control (product code DFT, Class 2, 21 CFR 866.5550). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on November 4, 1998, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DFT
- Device class
- 2
- Regulation
- 866.5550
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Japan | 1 |
| United Kingdom | 1 |
| France | 1 |
Makers of Igm, 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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | November 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | April 29, 1987 | 0 | 0 | 0 | api.fda.gov |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Manufacturer | 1 | November 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 1 | April 5, 1996 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 4, 1998. 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.