Data / Medical devices / Antibodies, Gliadin
Antibodies, Gliadin (MST): 15 FDA-registered makers in 4 countries
15 establishments in 4 countries are registered with the FDA to make Antibodies, Gliadin (product code MST, Class 2, 21 CFR 866.5750). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on July 28, 2017, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- MST
- Device class
- 2
- Regulation
- 866.5750
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 5 |
| Sweden | 1 |
| Italy | 1 |
Makers of Antibodies, Gliadin
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 |
|---|---|---|---|---|---|---|---|---|
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 8 | September 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 2 | December 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 2 | March 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 2 | March 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 2 | August 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 2 | August 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 2 | August 13, 2010 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 2 | March 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 1 | December 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Eurospital S.P.A. | Trieste, Italy | Manufacturer | 1 | December 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phadia GMBH | FREIBURG Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theratest Laboratories, Inc. | Lombard, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 28, 2017. 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.