Data / Medical devices / Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni (GNH): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Antigen, Fluorescent Antibody Test, Schistosoma Mansoni (product code GNH, Class 1, 21 CFR 866.3600). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on October 30, 1984, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GNH
- Device class
- 1
- Regulation
- 866.3600
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| United States | 4 |
| Switzerland | 1 |
Makers of Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
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 |
|---|---|---|---|---|---|---|---|---|
| Bordier Affinity Products SA | Crissier Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eiger Diagnostics, Inc. | Las Vegas, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gold Standard Diagnostics Frankfurt GmbH | Dietzenbach Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Life Diagnostics Inc. | Carlsbad, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 30, 1984. 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.