Liatest Protein S Kit

• • Terminated Z-1072-2007 FDA Unclassified (pre-2012) ·initiated 8 May 2007

  Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

510(k) Number

K912468 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the LIATEST PROTEIN S KIT used for?

  The LIATEST PROTEIN S KIT is used to assess Protein S levels in blood samples for qualitative and quantitative factor deficiency testing in hematology applications, helping evaluate coagulation disorders.

• How is the LIATEST PROTEIN S KIT supplied and intended for use?

  The LIATEST PROTEIN S KIT is supplied as a kit for in vitro diagnostic use and is intended for use in laboratory settings by qualified personnel to test blood samples for Protein S levels.

• What regulatory clearance does the LIATEST PROTEIN S KIT have?

  The LIATEST PROTEIN S KIT received FDA 510(k) clearance (K912468) on October 2, 1991, under regulation number 864.7290, and is classified as a Class II device with product code GGP.