BIOPHEN™ Factor IX (1 mL)
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BIOPHEN™ Factor IX (1 mL)

Code: A221801-RUO
Manufacturer’s Part Number: 221801-RUO
Product size: 2 x 1 mL
Clearance: RUO
Price: $411.00
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Product Description

In US and Canada: For Research Use Only. Not for Use in Diagnostic Procedures.

BIOPHEN™ FIX is a two-stage chromogenic assay for Factor IX activity in human citrated plasma or FIX concentrates. Clinical use: hemophilia B diagnosis and severity classification, FIX concentrate potency testing, and monitoring FIX replacement therapy (including extended half-life products). Components: R1 (FXIa + phospholipids + CaCl?), R2 (FXa chromogenic substrate), R3 (purified FX). Calibrate with BIOPHEN™ Plasma Calibrator (222101). Use Special Tris-BSA buffer (AR026). CE-IVD. 2x1 mL.

Product Characteristics

  • Total Assay Time: 10 min
  • Detection Threshold:
      High Range: 2%
      Low Range: 0.5%
  • Dynamic Range:
      High Range: 5 to 200%
      Low Range: 1 to 20%
  • Intra-Assay CV: 3 to 5%
  • Inter-Assay CV: 4 to 6%
  • Reference Material: NIBSC International standard

Product Components

  • R1: 2 x 1 mL Human FX and FVIII:C, lyophilized
  • R2: 2 x 1 mL Activation Reagent, lyophilized
  • R3: 2 x 1 mL Chromogenic substrate specific for FXa (SXa-11), lyophilized
  • R4: 2 x 15 mL Tris-BSA Buffer, ready to use
  

Product Applications

For the measurement of Factor IX activity in research applications.

Associated calibrator and controls are available: BIOPHEN™ Plasma Calibrator (Ref A222101-RUO), BIOPHEN™ Normal Control Plasma (Ref A223201-RUO) and BIOPHEN™ Abnormal Control Plasma (Ref A223301-RUO).

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents

  

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