EUDAMED device

INSTI HCV ANTIBODY TEST KIT

EUDAMED device 00686597200674 · bioLytical Laboratories Inc.

Key facts

Primary DI 00686597200674
Trade name INSTI HCV ANTIBODY TEST KIT
Device name INSTI HCV ANTIBODY TEST KIT
Reference or catalog number 90-1062
Model 90-1062
Manufacturer bioLytical Laboratories Inc.
Manufacturer SRN CA-MF-000023304
Risk class IVD Annex II List A
EMDN code W0105020303
EMDN description EPATITE C (HCV), ANTICORPI TOTALI|HCV ANTIBODY (TOTAL)|HÉPATITE C, ANTICORPS (TOTAL)
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:

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