STA-Liatest D-Di Test Kit

• • Ongoing Z-0205-2026 FDA Class II ·initiated 12 Sep 2025

  A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

510(k) Number

K964728 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the STA-Liatest D-Di Test Kit used for?

  The STA-Liatest D-Di Test Kit is an in vitro diagnostic device intended for quantitative measurement of D-dimer antigen levels in citrated plasma. D-dimer testing is commonly used in clinical settings to help diagnose conditions such as venous thromboembolism, deep vein thrombosis, and pulmonary embolism. The kit achieves this by performing immuno-turbidimetric assays, which measure light absorbance to determine antigen concentrations.

• Which analyzers is this test kit compatible with?

  This test kit is designed exclusively for use with STA analyzers manufactured by Diagnostica Stago in France. It is not compatible with other types of analyzers or systems, so compatibility must be confirmed with the manufacturer before use.

• Is the STA-Liatest D-Di Test Kit sterile?

  No, the STA-Liatest D-Di Test Kit is not sterile. It is supplied as a single-use diagnostic reagent, and proper handling and storage as outlined in the manufacturer’s instructions are required to ensure accuracy and reliability of results.

• How is the STA-Liatest D-Di Test Kit supplied?

  The kit is supplied as a single-use diagnostic reagent, meaning each kit is intended for one-time use only. This ensures consistency and reliability in test results while minimizing the risk of contamination or cross-reactivity between samples.

• What regulatory pathway does this device follow?

  The STA-Liatest D-Di Test Kit follows the FDA 510(k) clearance pathway, specifically under the classification of Class II medical devices with product code DAP. It was granted substantial equivalence (SESE) by the FDA’s Hematology (HE) advisory committee in 1997, confirming its compliance with regulatory standards for diagnostic devices in hematology.