This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | 2025-10-10 |
| US | K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | 2021-03-22 |
| US | K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | 2021-03-22 |
| BR | 80464810914 | IgG Screen Nutritional 88 ELISA | Class II |
| BR | 80464810915 | IgG4 Screen Nutritional 88 ELISA | Class II |
| BR | 80464810832 | Helicobacter pylori IgM ELISA | Class II |
| CA | 31493 | HCG ONE STEP TEST CASSETTES | Class II |
| CA | 91888 | THUNDERBOLT | Class II |