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# Diazyme Labs Vitamin D Assay Cleared
- URL: https://www.fdaweb.com/diazyme-labs-vitamin-d-assay-cleared/
- Published: 2018-01-22T12:00:00.000Z
- Updated: 2026-09-14T23:15:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140560

FDA has cleared a Diazyme Laboratories 510(k) to market its EZ Vitamin D Assay for clinical chemistry analyzers. This liquid-stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 plus 25-OH Vitamin D3) levels. The assay enables clinical laboratories of almost any size to run a Vitamin D test in house without the need for specialized instrumentation, the company says.