This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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 | K100499 | ORGENTEC RHEUMATOID FACTOR EIA | 2010-10-27 |
| US | K092399 | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | 2010-07-01 |
| US | K030929 | ANA DETECT | 2003-05-02 |
| BR | 80416660137 | ANCAscreen hs (high sensitive) | Class II |
| BR | 80416660138 | Anti-Gliadin IgG ORG 234G | Class II |
| BR | 80416660192 | Anti-Rib-P | Class II |
| CA | 68407 | ENA-4-PROFILE (EXTRACTABLE ANTI NUCLEAR ANTIBODY) | Class II |
| CA | 68415 | ANA DETECT | Class II |
| CA | 68416 | ANCACOMBI (ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODIES) | Class II |