Clotting Factor V Deficient Plasma

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K924394 ↗

FDA Product Code

GJT

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is Clotting Factor V Deficient Plasma used for?

  Clotting Factor V Deficient Plasma is an in vitro diagnostic reagent used to determine the activity of coagulation factor V. It is used with other methods to detect Factor V Leiden in citrated human plasma and helps diagnose congenital or acquired factor V deficiencies in patients with bleeding disorders.

• How is Clotting Factor V Deficient Plasma supplied?

  The product is supplied as a plasma product classified under the medical specialty of Hematology. It is manufactured by Behring Diagnostics, Inc. and is intended for use in laboratories for quantitative determination of coagulation factor V activity.

• What is the regulatory status of Clotting Factor V Deficient Plasma?

  Clotting Factor V Deficient Plasma has FDA 510(k) clearance with k number K924394. It is classified as a Class 2 device under regulation number 864.7290 and is regulated as a Plasma, Coagulation Factor Deficient product.

• What is the intended use of this diagnostic reagent?

  This reagent is intended for use in assays for the quantitative determination of coagulation factor V activity. It aids in the diagnosis of congenital or acquired factor V deficiencies in patients with bleeding disorders when used in conjunction with other methods.