EUDAMED device

ACCURUN 130 Borrelia burgdorferi IgG Positive Control

EUDAMED device 00816784020376 · LGC Clinical Diagnostics, Inc.

Key facts

Primary DI 00816784020376
Trade name ACCURUN 130 Borrelia burgdorferi IgG Positive Control
Device name ACCURUN 130 Borrelia burgdorferi IgG Positive Control
Reference or catalog number 2015-0080
Model 2015-0080
Manufacturer LGC Clinical Diagnostics, Inc.
Manufacturer SRN US-MF-000016356
Risk class IVD General
EMDN code W0105080801
EMDN description BACTERIOLOGY CONTROLS - INF.IMM.
Legislation ivdd
Implantable No
Sterile No
Single use No
Status date Jul 26, 2023

At a glance

  • Yes 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)

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