Wiener Lab. Calibrator A Plus, Model 2X3 mL Cat. Nr. 1918006

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.

Trade Name

Calibrador A plus

Model / Reference

1918005

Primary DI / UDI-DI

07798100043296

Basic UDI-DI

B-07798100043296

510(k) Number

K024305 ↗

FDA Product Code

JIX

EMDN Code

W0101050301 Calibrators multicomponent (cc)

Device Class

Class IVD General EUDAMED

Class II 510(k)

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Wiener Lab. Calibrator A Plus in a clinical chemistry lab?

  The Wiener Lab. Calibrator A Plus is designed as a multi-analyte mixture calibrator to ensure the accuracy and precision of automated chemistry analyzers. It provides predefined concentrations of analytes, serving as a reference standard for calibration to maintain reliable assay performance in clinical chemistry testing.

• How is the Wiener Lab. Calibrator A Plus supplied, and is it intended for single-use?

  The calibrator is supplied as a single-use liquid in a 2×3 mL volume. It is explicitly intended for in vitro diagnostic use only and is not designed for reuse or reprocessing, as per manufacturer guidelines.

• Does this calibrator require any special storage conditions, and can it be reused?

  The device requires proper storage as specified by Wiener Laboratories, though exact conditions (e.g., temperature, light exposure) are not detailed in the provided data. Importantly, it is not intended for reuse or reprocessing—each unit is a single-use item.

• What regulatory pathways does the Wiener Lab. Calibrator A Plus follow, and what class is it assigned?

  The calibrator is authorized under FDA 510(k) and IVDD (In Vitro Diagnostic Directive) regulations. It is classified as a Class II medical device, with a decision of *Substantially Equivalent* (SESE) for its clinical chemistry applications.

• Are there any safety considerations for this calibrator, such as MRI compatibility?

  The provided data does not include any information regarding MRI safety for the Wiener Lab. Calibrator A Plus. Clinicians should assume it is not MRI-compatible unless explicitly stated otherwise by the manufacturer.