This company has registrations in United States, Brazil, Canada — 3 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 | K253539 | Alere NT-proBNP for Alinity i | 2026-02-18 |
| US | K241176 | Alere NT-proBNP for Alinity i Reagent Kit | 2025-01-16 |
| US | K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | 2024-07-31 |
| BR | 80213250636 | Active-B12 (Holotranscobalamina) EIA | Class II |
| BR | 80213250565 | Solução tamponada de lavagem Homocisteina EIA | Class I |
| BR | 80213250566 | Homocisteina EIA | Class II |
| CA | 72306 | AXSYM ACTIVE-B12 | Class II |
| CA | 73423 | AXSYM ANTI-CCP | Class II |
| CA | 76694 | AXSYM HBA1C ASSAY | Class II |