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.
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | 2007-05-25 |
| US | K980180 | 2700 SAMPLE MANAGER | 1998-02-12 |
| US | K973074 | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | 1997-10-06 |
| BR | 81531370006 | RenataDX System | Class II |
| BR | 81531370003 | ACQUITY UPLC I-CLASS IVD / XEVO TQ-S MICRO IVD | Class II |
| BR | 81531370002 | Família de instrumentos Acquity UPLC IVD | Class II |
| CA | 80663 | MASSTRAK IMMUNOSUPPRESSANTS KIT | Class III |
| CA | 82045 | NEOLYNX SCREENING APPLICATION MANAGER SOFTWARE | Class II |