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Maglumi 25-OH Vitamin D, Maglumi X3 Fully-Auto Chemiluminescence Immunoassay Analyzer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232587

by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Identifiers

510(k) Number
K232587 FDA 510(k)
FDA Product Code
MRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1825 FDA 510(k)
Regulation Number
862.1825 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Maglumi 25-OH Vitamin D and Maglumi X3 Fully-Auto Chemiluminescence Immunoassay Analyzer is a fully automated in-vitro diagnostic system designed for quantitative and qualitative chemiluminescence immunoassays. It measures 25-hydroxyvitamin D levels, a key biomarker for assessing vitamin D status and related metabolic disorders.

This analyzer is intended for use in clinical chemistry laboratories and operates as a fully automated, high-throughput system. Supplied as a reusable device, it requires appropriate training and maintenance in compliance with regulatory standards. The system holds FDA 510(k) and IVDR authorizations, ensuring adherence to stringent safety and performance criteria for in-vitro diagnostic use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.

Sources (2)

  • FDA 510(k) K232587 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026