Data / Medical devices / Antigens, All Types, Escherichia Coli
Antigens, All Types, Escherichia Coli (GMZ): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Antigens, All Types, Escherichia Coli (product code GMZ, Class 1, 21 CFR 866.3255). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on April 17, 2023, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GMZ
- Device class
- 1
- Regulation
- 866.3255
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 2 |
| Germany | 1 |
| Denmark | 1 |
| Canada | 1 |
Makers of Antigens, All Types, Escherichia Coli
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 |
|---|---|---|---|---|---|---|---|---|
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer, Specification developer | 3 | April 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Manufacturer | 2 | April 23, 1998 | 0 | 0 | 0 | api.fda.gov |
| Techlab, Inc. | Radford, VA, United States | Manufacturer | 2 | October 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Techlab, Inc. | Blacksburg, VA, United States | Manufacturer | 2 | October 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Bbi Solutions Oem Limited | Crumlin Newport, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merck Kgaa | DARMSTADT Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSI Diagnostica A/S | Hilleroed Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| pro-lab incorporated | Richmond Hill Ontario, Canada | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 17, 2023. 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.