BIOPHEN™ Dabigatran Control Plasma

$339.00

2 x 6 x 1 mL. Normal human plasma, freeze dried, with Dabigatran at two different concentrations (high and low). Available online.

SKU: A224701-RUO

Manufacturer: Hyphen BioMed

Categories: Calibrators & Controls, Controls, Dabigatran

Product Description

In US: For Research Use Only. Not for Use in Diagnostic Procedures. Lyophilized plasmas, at defined Dabigatran concentrations (2 levels of about 100 and 300 ng/mL), as measured with the HEMOCLOT Thrombin Inhibitors kit , for the quality control of Dabigatran measurements with clotting or chromogenic assays. 2 x 6 x 1 mL. Normal human plasma, freeze dried, with Dabigatran at two different concentrations (high and low). Available online.

Product Documents & Features

Quality control of anti-IIa clotting and chromogenic assays for Dabigatran (e.g., HEMOCLOT™ Thrombin Inhibitors, Ref ACK002K-RUO / ACK002L-RUO, Low Range Protocol). Please Note: This product is intended for Research Use Only (RUO) in the US, and must bear RUO labeling per FDA regulations. Alternate CE Mark (IVD) labeling for use in countries outside the US is available below.

Normal human plasma, freeze dried, with Dabigatran, at two different concentrations (high and low).
High stability following reconstitution.
Dabigatran Controls are accurately determined against an Internal Reference Standard, initially validated against fresh reference preparations of dabigatran, and confirmed with a physico-chemical method (HPLC).

12 vials (6 sets of 2 vials) of 1 mL of human plasma supplemented at 2 different concentrations of dabigatran.
Video of Product Components(Video can be viewed with Flash Plugin)

COA (3)

COA Document COA Document 2 COA Document 3

IFU (1)

IFU Document 1