Il Test Antithrombin

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K980499 ↗

FDA product code

JBQ

Device class

Class II

Regulation

21 CFR Part 864.7060

Advisory committee

Hematology

FDA decision

SESE Substantially Equivalent

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• What is the IL Test Liquid Antithrombin used for?

  The IL Test Liquid Antithrombin is a chromogenic assay designed for the quantitative measurement of Antithrombin III in human citrated plasma. It supports clinical assessments in hematology to diagnose both hereditary and acquired Antithrombin deficiencies, helping clinicians evaluate coagulation disorders accurately.

• How is the IL Test Liquid Antithrombin supplied and prepared for use?

  This assay is supplied as a liquid, ready-to-use reagent, eliminating the need for additional preparation steps. It is specifically intended for automated use in clinical laboratories, ensuring compatibility with standard laboratory workflows and instrumentation.

• Is the IL Test Liquid Antithrombin sterile and single-use?

  No, the IL Test Liquid Antithrombin is not sterile and is intended for single-use only. Sterility is not required for this type of assay, as it is designed for immediate use in controlled laboratory environments where contamination risks are managed through standard aseptic techniques.

• What storage conditions are required for the IL Test Liquid Antithrombin?

  The IL Test Liquid Antithrombin does not require special storage conditions beyond those outlined in the accompanying instructions. It should be stored according to the manufacturer’s guidelines to maintain stability and performance, typically involving protection from extreme temperatures and light.

• Is this device approved for use in the United States?

  Yes, the IL Test Liquid Antithrombin is authorized for use in the United States under FDA 510(k) clearance (K980499). This clearance confirms its substantial equivalence to a predicate device and compliance with regulatory standards for hematology testing, ensuring its suitability for clinical diagnostic purposes.