This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia — 6 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 |
|---|---|---|---|
| EU | EVIRBTCFDK1 | Borrelia All-In-One ViraChip Deca Kit | IVD B |
| EU | EVIRBTCFOK1 | Borrelia All-In-One ViraChip Test Kit | IVD B |
| EU | EVIRBSCMDK1 | Borrelia ViraChip IgM Deca Kit | IVD B |
| EU | EVIRBSCMOK1 | Borrelia ViraChip IgM Test Kit | IVD B |
| UK | 50540 | ViraChip | IVD general |
| UK | 50541 | ViraChip | IVD general |
| UK | 63901 | ViraChip | IVD general |
| US | K220016 | Viramed Borrela All-In-One ViraChip Test Kit | 2022-08-19 |
| US | K163695 | Borrelia B31 ViraChip IgM Test Kit | 2017-08-22 |
| US | K163504 | Borrelia B31 ViraChip IgG Test Kit | 2017-07-12 |
| BR | 10230730187 | Liver ViraChip® IgG Test Kit | Class II |
| BR | 10230730191 | Família ANA plus ViraChip® IgG | Class II |
| BR | 10230730160 | ViraChip® Sample Buffer | Class I |