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 | K160606 | BC-5D Hematology Control | 2016-09-01 |
| US | K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | 2013-07-24 |
| US | K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | 2011-04-28 |
| BR | 81154840030 | XERet Control | Class II |
| BR | 81154840031 | CBC-LINE | Class II |
| BR | 10246810345 | CONTROLE HEMATOLOGICO CBC-5DMR TRI PACK | Class II |
| CA | 15619 | PLATELET TROL-II CONTROL | Class II |
| CA | 68322 | HUMAN STFR QUANTIKINE IVD KIT (TRANSFERRIN RECEPTOR) | Class II |
| CA | 68323 | QUANTIKINE IVD HUMAN B2-MICROGLOBULIN | Class II |