Factor IX Deficient Plasma

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K900409 ↗

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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• Dulbecco's Modified Eagle's Med. (Dme) W/Glucose a

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• Dulbecco's Modified Eagle #D5523-

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• Ast Reagent (Procedure Number 158)

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• (Mem) Eagle No. M3024 W/Earle's Salts

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See all devices from Sigma Chemical Co. →

• What is Factor IX Deficient Plasma used for?

  Factor IX Deficient Plasma is a human plasma product used as a control material in coagulation testing laboratories to help diagnose and monitor conditions related to factor IX deficiency, such as hemophilia B.

• How is Factor IX Deficient Plasma supplied?

  The product is supplied as a liquid and is intended for laboratory use only. It is not indicated for therapeutic use and should be handled according to laboratory protocols for plasma products.

• What is the regulatory status of Factor IX Deficient Plasma?

  Factor IX Deficient Plasma is regulated by the FDA under product code GJT with 510(k) clearance K900409. It is classified as Class II and is manufactured by Sigma Chemical Co. for laboratory diagnostic purposes only.

• Is Factor IX Deficient Plasma sterile?

  The device data does not specify sterility information. As a laboratory control material, it should be handled according to standard laboratory safety protocols for human plasma products.