This company has registrations in United States, Saudi Arabia, 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K240854 | Accelerate Arc System | 2024-09-26 |
| US | K192665 | Accelerate Pheno System, Accelerate PhenoTest BC Kit | 2020-09-15 |
| US | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | 2017-02-23 |
| SA | ME0000012817SFDAA00005 | Accelerate Arc BC KIT | — |
| CA | 104354 | ACCELERATE PHENO SYSTEM | Class II |
| CA | 104380 | ACCELERATE PHENOTEST BC ID AND AST QC TEST(S) | Class II |