BIOPHEN™ FIX (2.5 mL)
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BIOPHEN™ FIX (2.5 mL)

Code: A221802-CAN
Manufacturer’s Part Number: 221802
Product size: 2 x 2.5 mL
Clearance: CE / HCL
Price: $567.00
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Product Description

In EU: This Product is CE Marked.

Health Canada Licensed.

BIOPHEN™ FIX chromogenic Factor IX activity assay. For hemophilia B diagnosis, FIX concentrate potency (including extended half-life products: AlprolixŽ, IdelvionŽ, RebinynŽ), and monitoring FIX replacement therapy. Two-stage method per EP/USP. CE-IVD. 2x2.5 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%
  • Number of Tests (Manual Microplate Method): 2 x 50 Tests
  • Reference Material: NIBSC International standard

Product Components

  • R1: 2 x 2.5 mL Human FX and FVIII:C, lyophilized.
  • R2: 2 x 2.5 mL Activation Reagent, lyophilized.
  • R3: 2 x 2.5 mL Chromogenic substrate specific for FXa (SXa-11), lyophilized.
  • R4: 2 x 25 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-CAN), BIOPHEN™ Normal Control Plasma (Ref A223201-CAN) and BIOPHEN™ Abnormal Control Plasma (Ref A223301-CAN).

Please Note: IVD Not for Sale in US. For US availability CLICK HERE.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents

  

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A222101-CAN BIOPHEN™ Plasma Calibrator    $318.00  

   
A223201-CAN BIOPHEN™ Normal Control Plasma    $175.00  

   
A223301-CAN BIOPHEN™ Abnormal Control Plasma    $175.00  

   
A221806-CAN BIOPHEN™ FIX (6 mL)    $987.00