PRODUCT DESCRIPTION

In US: This product is 510(k) Cleared for In Vitro Diagnostic Use. Quality control plasma presenting an Activated Protein C Resistance (heterozygous), tested for Factor V-L concentration.

Quality control plasma for the qualitative or quantitative assay of FV-Leiden (resistant to APC), with clotting assays. In US: This product is 510(k) Cleared for In Vitro Diagnostic Use.

PRODUCT CHARACTERISTICS

Normal human citrated plasmas, freeze dried and stabilized, titrated for various factor activities.

Concentrations are established against a reference preparation from normal donors and patients presenting APC resistance (FVL).

High stability following reconstitution.

PRODUCT COMPONENTS

12 x 0.5 mL of human plasma, presenting an APC-R, citrated and lyophilized.

PRODUCT APPLICATION