This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 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.
Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | 2025-10-17 |
| US | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | 2025-05-23 |
| US | K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | 2024-01-24 |
| BR | 81357320001 | Optilite IgG1 Kit | Class II |
| BR | 81357320002 | Optilite IgG Kit | Class II |
| BR | 81357320005 | Optilite Diluent 3 | Class I |
| CA | 18652 | AUTO ANTIBODIES SCREENING TESTS | Class II |
| CA | 18653 | HUMAN IGG SUBCLASSES SINGLE DILUTION BINDARID KITS | Class II |
| CA | 18654 | MONKEY OESOPHAGUS IFA | Class II |