BIOPHEN™ FVIII Variant — Emicizumab-Insensitive FVIII Assay (Bovine FX)
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BIOPHEN™ FVIII Variant — Emicizumab-Insensitive FVIII Assay (Bovine FX)

Code: A227102-RUO
Manufacturer’s Part Number: 227102
Product size: Kit
Clearance: RUO
Price: $461.00
Qty
 

Product Description

For Research Use Only. Not for Use in Diagnostic Procedures.

Chromogenic assay for Factor VIII activity using bovine Factor X (FX) reagents — specifically designed to be insensitive to Emicizumab (Hemlibra®). CE-IVD.

When patients on Emicizumab require accurate measurement of their endogenous or infused FVIII separately from Emicizumab activity, this bovine-FX design is required. The human-FX based BIOPHEN™ FVIII:C detects Emicizumab; this variant does not.

  • Bovine Factor X — insensitive to Emicizumab (Hemlibra®)
  • For true FVIII:C quantification in Emicizumab-treated hemophilia A patients
  • Complete with R1/R2/R3 reagents and R4 buffer

Product Characteristics

  • R1: Bovine Factor X at approximately 7.5 µg/mL, lyophilized. Contains a fibrin polymerization inhibitor, BSA and stabilizers.
  • R2: Activation Reagent, human Factor IIa at approximately 1 NIH/mL, human Factor IXa at approximately 2 µg/mL and synthetic Phospholipids (1:40 dilution), lyophilized. Contains BSA, Calcium Chloride Dihydrate and stabilizers.
  • R3: SXa-11, chromogenic substrate specific to Factor Xa (CS-11(32)) at approximately 6 mg/mL, lyophilized. Contains stabilizers and EDTA disodium salt.H373: May cause damage to organs through prolonged or repeated exposure.
  • R4: Tris-BSA Buffer, liquid. Contains BSA, human acid glycoprotein (AGP), stabilizers and preservatives.

Product Components

  

Product Applications

Chromogenic method for the in vitro quantitative determination of Factor VIII (FVIII) activity, in human citrated plasma or FVIII concentrates, using an automated method.

This method is for the detection of FVIII deficiency states and monitoring of replacement therapy (except Emicizumab) on patients who are suspected of congenital or acquired deficiency and potency estimation of FVIII concentrates.

This device of in vitro diagnostic use is intended for professional use in the laboratory.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents