This company has registrations in United States, Canada, South Korea, Australia, Hong Kong — 5 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 | DEN190023 | AmplideX Fragile X Dx & Carrier Screen Kit | 2020-02-21 |
| US | DEN160003 | Quantidex qPCR BCR-ABL IS Kit | 2016-07-22 |
| US | K113420 | RNARETAIN | 2012-03-16 |