Sta-Cephascreen Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K053111 ↗

FDA product code

GFO

Device class

Class II

Regulation

21 CFR Part 864.7925

Advisory committee

Hematology

FDA decision

SESE Substantially Equivalent

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See all devices from Diagnostica Stago, Inc. →

• What is the primary function of the Sta-Cephascreen Kit?

  The Sta-Cephascreen Kit is an activated partial thromboplastin time (APTT) clotting assay. It is designed for laboratory use to measure the clotting time of blood plasma, utilizing a reagent that includes cephalin derived from rabbit cerebral tissues and a polyphenolic activator in a buffered medium.

• How is the Sta-Cephascreen Kit regulated?

  The Sta-Cephascreen Kit is classified as a class 2 medical device and has received FDA 510(k) clearance under K053111. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the hematology specialty.

• What components are included in the Sta-Cephascreen Kit?

  The kit is supplied as a laboratory reagent system. It contains a specific reagent formulation consisting of a platelet substitute, which is cephalin derived from rabbit cerebral tissues, combined with a polyphenolic activator suspended in a buffered medium to facilitate the APTT clotting assay process.