BIOPHEN™ FVIII:C
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BIOPHEN™ FVIII:C

Code: A221402-RUO
Manufacturer’s Part Number: 221402-RUO
Product size: 2 x 2.5 mL
Clearance: RUO
Price: $549.00
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Product Description

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

BIOPHEN™ FVIII:C is a two-stage chromogenic assay for Factor VIII coagulant activity (FVIII:C) in human citrated plasma or FVIII concentrates, per European Pharmacopoeia and USP methods. Components: R1 (activated FIXa + FX + phospholipids + CaCl?), R2 (Factor Xa chromogenic substrate). Clinical applications: hemophilia A diagnosis and severity classification (severe <1%, moderate 1-5%, mild 5-40%), FVIII concentrate potency testing, monitoring FVIII replacement therapy, and DDAVP response assessment. Note: This assay IS sensitive to emicizumab — for emicizumab-treated patients, use BIOPHEN™ FVIII Variant (227102) instead. Calibrate with BIOPHEN™ Plasma Calibrator (222101). QC with Normal (223201) and Abnormal (223301) Controls. Use Special Tris-BSA buffer (AR026) for dilutions. CE-IVD.

Product Characteristics

  • Total Assay Time: ≤ 10 min
  • Detection Threshold:
      High Range: 10%
      Low Range: 0.2%
  • Dynamic Range:
      High Range: 5 to 200%
      Low Range: 1 to 25%
  • Intra-Assay CV: 3 to 5%
  • Inter-Assay CV: 4 to 7%
  • Number of Tests (Manual Microplate Method): 2 x 50 Tests
  • Reference Material: FVIII:C International Standard

Product Components

  • R1: 2 x 2.5 mL Human FX, 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+: 4 x 25 mL Tris-BSA Buffer, ready to use.
  

Product Applications

Measurement of Factor VIII:C 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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