This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 8 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 | K921045 | DIASLIDE URINE CULTURING DEVICE | 1992-09-28 |
| US | K914327 | SEROELISA(TM) CHLAMYDIA IGA TEST KIT | 1992-06-09 |
| US | K915281 | SEROLISA CHLAMYDIA IGG TEST KIT | 1992-03-23 |
| BR | 80464810703 | H. pylori Saliva Test | Class II |
| BR | 80464810781 | Vaginal Yeast Test | Class II |
| CA | 12843 | SERI CT IGA | Class III |
| CA | 12844 | SEROCP-IGM | Class III |
| CA | 12847 | SERO CT IGG | Class III |