This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 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 | K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | 2004-06-10 |
| US | K024173 | CDS 3-PD HEMATOLOGY CONTROLS | 2003-01-14 |
| US | K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | 1999-12-20 |
| BR | 81298810001 | Swelab Alfa Diluent (Swelab Alfa Diluente) | Class I |
| BR | 81298810002 | Quintus 5-part Diluent (Quintus 5 partes Diluente) | Class I |
| BR | 81298810003 | Quintus 5-part Stopper (Quintus 5 partes Parada) | Class I |
| CA | 15332 | CDS HEMATOLOGY CONTROLS | Class II |
| CA | 16183 | CDS - CAL HEMATOLOGY CALIBRATOR | Class II |