VIDAS Lyme IgM

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Model / Reference

30319

Primary DI / UDI-DI

03573026265083

Basic UDI-DI

357302BUDI000084TA

510(k) Number

K122979 ↗

FDA Product Code

LSR

EMDN Code

W0105010604 Lyme antibody igm

Device Class

Class B EUDAMED

Class II 510(k)

Regulation

21 CFR Part 866.3830

Market of Registration

France

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomerieux S.A. →

• What is the VIDAS Lyme IgM reagent used for in a clinical setting?

  The VIDAS Lyme IgM is designed for the qualitative detection of IgM antibodies to *Borrelia burgdorferi* in human serum or plasma. It helps identify markers associated with Lyme disease, aiding in microbiological testing for diagnostic purposes.

• How is the VIDAS Lyme IgM reagent supplied and intended for use?

  The reagent is supplied as a single-use item and is intended exclusively for use with the VIDAS automated immunoassay system, a fully integrated diagnostic platform. No additional sterilization is required, as it is pre-packaged for one-time use.

• Is the VIDAS Lyme IgM reagent reusable, or is it meant for single-use only?

  The VIDAS Lyme IgM is explicitly designed as a single-use reagent. This ensures consistency and reliability in testing, as it is not intended for reuse or reprocessing.

• What regulatory pathways has the VIDAS Lyme IgM followed for approval?

  The device has been granted FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). It is also compliant with the In Vitro Diagnostic Regulation (IVDR) in Europe, reflecting its classification as a Class B or C device for microbiological testing.

• Where can I find detailed storage instructions for the VIDAS Lyme IgM reagent?

  Storage conditions and shelf life details are provided in the accompanying Instructions for Use (IFU). These guidelines specify how to properly store the reagent to maintain its integrity and performance, ensuring accurate diagnostic results.