BIOPHEN™ Abnormal Control Plasma
BIOPHEN™ Abnormal Control Plasma
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Product Summary:
BIOPHEN™ Abnormal Control Plasma (223301) is an Abnormal Control Plasma for coagulation assay quality control. Manufactured by HYPHEN BioMed.
Intended Use
The BIOPHEN™ Abnormal Control Plasma kit is a set of citrated human plasma, lyophilized, intended for the quality control of some coagulation factors assays.
Summary and Explanation
Technical The following table shows the various parameters, which are measured using assays from HYPHEN BioMed or other manufacturers, and according to the package inserts:
Parameters Method PT/INR/% and aPTT Activity Fibrinogen (Fbg) Activity / Antigen Lupus Anticoagulant (LA) Activity α2 – Antiplasmin (α2-AP) Activity Antithrombin (AT) Activity / Antigen Prothrombin (FII) Activity Factor V (FV) Activity Factor VII (FVII) Activity Factor VII + X (FVII + X) Activity Factor VIII:C (FVIII) Activity Factor IX (FIX) Activity Factor X (FX) Activity Factor XI (FXI) Activity Factor XII (FXII) Activity Factor XIII (FXIII) Activity Plasminogen (Plg) Activity Protein C (PC) Clotting activity Protein C (PC) Chromogenic activity Protein C (PC) Antigen Protein S (PS) Clotting activity Free Protein S (Free PS) Antigen von Willebrand Factor Antigen (vWF: Ag) Antigen The BIOPHEN™ Abnormal Control Plasma is tested for the absence of Lupus Anticoagulant. It can be used as a negative control for this investigation.
Reagents
C2 Abnormal citrated human plasma, lyophilized.
12 vials of 1mL.
Control plasma contains stabilizing agents.
The control concentrations may vary slightly from one batch to another. For the assay, see the exact values indicated on the flyer provided with the kit used.
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Product RangeProduct Code223301Product NameBIOPHEN™ Abnormal Control PlasmaProduct CategoryProduct BrandProduct Analyte or ApplicationAntithrombin (AT)
Factor II (FII)
Factor IX (FIX)
Factor V (FV)
Factor VII (FVII)
Factor VII + X (FVII + X)
Factor VIII:C (FVIII:C)
Factor X (FX)
Factor XI (FXI)
Factor XII (FXII)
Factor XIII (FXIII)
Fibrinogen (FIB)
Free Protein S (Free PS)
Lupus Anticoagulant (LA)
Plasminogen (PLG)
Protein C (PC)
Prothrombin (FII)
PT/INR/aPTT
von Willebrand Factor Antigen (vWF: Ag)
α2-Antiplasmin (α2-AP)Product Size12 x 1 mlProduct Storage2°C to 8°CProduct IVD Registration Status510(k)
CE-Mark - Professional Use
UKCA -
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