This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 8 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.
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | 2017-10-23 |
| US | K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | 2017-02-01 |
| US | K140455 | CAPTIA MEASLES IGM | 2014-05-22 |
| BR | 80944340001 | PREMIER HB9210 ANALISADOR DE HEMOGLOBINAS | Class II |
| BR | 80944340013 | ANALISADOR PREMIER RESOLUTION | Class II |
| BR | 80944340003 | HEMOGLOBINA A1c CALIBRADORES | Class II |
| CA | 8571 | BARTELS FLUORESCENT ANTINUCLEAR ANTIBODY TEST | Class II |
| CA | 11850 | BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY | Class II |
| CA | 13291 | BARTELS CHLAMYDIA IMMUNOPEROXIDASE TEST | Class III |