This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 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 | K183446 | BioPlex 2200 Lyme Total | 2019-03-12 |
| US | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | 2019-02-13 |
| US | K180577 | BioPlex 2200 25-OH Vitamin D Kit | 2018-06-22 |
| BR | 80020690280 | VARIANT II TURBO HbA1c Kit 2.0 | Class II |
| BR | 80020690415 | Família InteliQ Urine Chemistry Control | Class II |
| BR | 80020690283 | Hemoglobin Capillary Collection System (HCCS) | Class I |
| SA | ME0000001388SFDAA00001 | Sample Vials, 100 X 1.5 mL | — |
| SA | ME0000001021SFDAA00636 | Instrument Probe Cleaning Solution | — |
| CA | 105 | GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA | Class IV |
| CA | 2441 | KALLESTAD TOTAL ANTI-CARDIOLIPIN SCREEN MICROPLATE EIA | Class II |
| CA | 2445 | SANOFI DIAGNOSTICS PASTEUR KALLESTAD ANTI-THYROID PEROXIDASE (TPO) MICROPLATE EIA | Class II |