EUDAMED device
INSTI Multiplex Test Kit
EUDAMED device 00686597200445 · bioLytical Laboratories Inc.
Key facts
| Primary DI | 00686597200445 |
|---|---|
| Trade name | INSTI Multiplex Test Kit |
| Device name | INSTI Multiplex Test Kit |
| Reference or catalog number | 90-1028 |
| Model | 90-1028 |
| Manufacturer | bioLytical Laboratories Inc. |
| Manufacturer SRN | CA-MF-000023304 |
| Risk class | IVD Annex II List A |
| EMDN code | W0105010302,W0105030402 |
| EMDN description | HIV1/2, ANTICORPI|HIV MULTIPLE ANTIBODY|SIFILIDE (LUE), ANTICORPI TOTALI|SYPHILIS ANTIBODY ASSAYS TOTAL|SYPHILIS, ANTICORPS TOTAUX|VIH DÉCTECTION COMBINÉE VIH 1 ET VIH 2, ANTICORPS |
| Legislation | ivdd |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | May 25, 2022 |
At a glance
- No Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: