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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel | 2025-01-08 |
| US | K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | 2024-07-10 |
| US | K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | 2020-02-21 |
| BR | 10358940141 | KingFisher Apex Dx Purification Instrument | Class I |
| BR | 10358940139 | Ion Torrent Genexus Dx Purification System | Class I |
| BR | 10358940104 | Calibradores para QuantStudio 5 DX Placa III | Class I |