Data / Medical devices / Antisera, All Types, Escherichia Coli
Antisera, All Types, Escherichia Coli (GNA): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Antisera, All Types, Escherichia Coli (product code GNA, Class 1, 21 CFR 866.3255). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on October 2, 2007, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GNA
- Device class
- 1
- Regulation
- 866.3255
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| United Kingdom | 2 |
| Denmark | 1 |
| Canada | 1 |
Makers of Antisera, 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 |
|---|---|---|---|---|---|---|---|---|
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Specification developer | 3 | February 28, 2000 | 0 | 0 | 0 | api.fda.gov |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer, Manufacturer | 1 | November 1, 1996 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 1 | April 20, 1994 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Merydi Bio-Tech Co., Ltd. | changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Wancheng Bio-Electron Co., Ltd. | Changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Hongyi Bio-Tech Co., Ltd. | Changchun Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lee Laboratories, Inc. | Grayson, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 1 | 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 2, 2007. 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.