Factor XII Deficient Plasma

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

510(k) Number

K900412 ↗

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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  Class I

  FDA 510(k) K896092 Active Cleared 9 Nov 1989

• Apolipoprotein a-I (Apo a-I)

  Class I

  FDA 510(k) K901675 Active Cleared 26 Apr 1990

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

  Class I

  FDA 510(k) K850092 Active Cleared 27 Feb 1985

• Dulbecco's Modified Eagle #D5523-

  Class I

  FDA 510(k) K832688 Active Cleared 12 Sep 1983

• Ast Reagent (Procedure Number 158)

  Class II

  FDA 510(k) K892844 Active Cleared 20 Jun 1989

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

  Class I

  FDA 510(k) K873093 Active Cleared 25 Aug 1987

See all devices from Sigma Chemical Co. →

• What is Factor XII Deficient Plasma used for?

  Factor XII Deficient Plasma is used as a diagnostic reagent in hematology testing to assess the intrinsic pathway of coagulation, specifically to detect or measure Factor XII activity or deficiency in laboratory assays.

• How is Factor XII Deficient Plasma supplied and intended for use?

  Factor XII Deficient Plasma is supplied as a plasma preparation and is intended for in vitro diagnostic use in laboratory settings to evaluate coagulation function via the intrinsic pathway.

• Is Factor XII Deficient Plasma sterile, single-use, or reusable?

  The provided data does not describe Factor XII Deficient Plasma as sterile, single-use, or reusable; therefore, no claims about sterility or reusability can be made based on the available information.