This company has registrations in United States, Canada, Israel — 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | 2004-06-18 |
| US | K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | 2003-09-05 |
| US | K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | 1999-09-09 |
| CA | 62402 | CHOLESTECH GDX SYSTEM | Class III |