EUDAMED device

INSTI HIV-1/HIV-2 Control Test

EUDAMED device 00686597010365 · bioLytical Laboratories Inc.

Key facts

Primary DI 00686597010365
Trade name INSTI HIV-1/HIV-2 Control Test
Device name INSTI HIV-1/HIV-2 Control Test
Reference or catalog number 90-1036
Model 90-1036
Manufacturer bioLytical Laboratories Inc.
Manufacturer SRN CA-MF-000023304
Risk class IVD Annex II List A
EMDN code W0105094001
EMDN description CONTRÔLES POUR SÉROLOGIE INFECTIEUSE/«POINT OF CARE» - TESTS RAPIDES ET BIOLOGIE MOLÉCULAIRE|CONTROLLI PER IMMUNOLOGIA INFETTIVA/NAT- TEST RAPIDI E POINT OF CARE|CONTROLS INFECTIOUS IMMUNOLOGY/NAT…
Legislation ivdd
Implantable No
Sterile No
Single use No
Status date May 25, 2022

At a glance

  • No Matching FDA GUDID record

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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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