Antithrombin III Screen Kit

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

510(k) Number

K812215 ↗

FDA Product Code

JBQ

Device Class

Class II

Regulation

21 CFR Part 864.7060

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Prothrombin Reference Plasma (Human)

  Class II

  FDA 510(k) K791022 Active Cleared 24 Jul 1979

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  Class II

  FDA 510(k) K972627 Active Cleared 13 Aug 1997

• Thrombostrate Control Plasmas

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• Thromboscreen Thromboplastin-Ds

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  FDA 510(k) K940082 Active Cleared 14 Feb 1995

• Thromboscreen Aptt Reagent

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  FDA 510(k) K891337 Active Cleared 21 Apr 1989

• Heparin Control Plasma Level 1

  Class II

  FDA 510(k) K992278 Active Cleared 26 Aug 1999

See all devices from Pacific Hemostasis →

• What is the Antithrombin III Screen Kit used for?

  The Antithrombin III Screen Kit is designed to measure antithrombin III levels in plasma, helping clinicians diagnose and monitor conditions like hereditary or acquired antithrombin deficiency. These deficiencies can increase the risk of thrombotic events, so accurate quantitation supports informed decision-making in hematology.

• How is the Antithrombin III Screen Kit supplied and stored?

  The kit is supplied as a single-use reagent system intended for laboratory use. It requires standard refrigeration between 2–8°C and does not need additional storage precautions. This ensures stability and reliability for quantitative testing in clinical settings.

• Is the Antithrombin III Screen Kit intended for reuse or single-use?

  The kit is explicitly designed for single-use only. This prevents cross-contamination and maintains accuracy in measuring antithrombin III levels, adhering to best practices for in vitro diagnostic devices.

• What type of instrumentation is required to use the Antithrombin III Screen Kit?

  The kit is intended for use in clinical laboratories equipped with coagulation analyzers. These analyzers are standard in hematology settings and ensure precise quantitation of antithrombin III, enabling reliable clinical assessment.

• Does the Antithrombin III Screen Kit have any special regulatory considerations?

  The kit holds FDA 510(k) clearance under the Hematology advisory committee and is classified as a Class II device (product code JBQ, regulation number 864.7060). No MRI safety concerns apply, as it is not intended for use in magnetic resonance environments.