EUDAMED device

Isletest™ IAA ELISA

EUDAMED device 00083059070118 · Biomerica, Inc.

Key facts

Primary DI 00083059070118
Trade name Isletest™ IAA ELISA
Device name Isletest™ IAA ELISA
Reference or catalog number 7011
Model 7011
Manufacturer Biomerica, Inc.
Manufacturer SRN US-MF-000015772
Risk class IVD General
EMDN code W0102060104
EMDN description INSULIN ANTIBODY
Legislation ivdd
Implantable No
Sterile No
Single use No
Status date Sep 24, 2024

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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