BIOPHEN™ FVIII:C Chromogenic Assay (2 × 6 mL)
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BIOPHEN™ FVIII:C Chromogenic Assay (2 × 6 mL)

Code: A221406-CAN
Manufacturer’s Part Number: 221406
Product size: 2 x 6 mL
Clearance: CE / HCL
Price: $924.00
Qty
 

Product Description

Chromogenic assay for Factor VIII coagulant activity (FVIII:C) in citrated human plasma or therapeutic FVIII concentrates. Uses human Factor IX and Factor X reagents — validated for Emicizumab (Hemlibra®) "FVIII-like" activity measurement. CE-IVD.

  • Two working ranges: low range (0.5–25%) for severe hemophilia A, high range (2–200%) for moderate/mild and concentrates
  • Human FIX/FX design detects Emicizumab (Hemlibra®) FVIII-like activity
  • Traceable to WHO international FVIII standard via BIOPHEN™ Plasma Calibrator (222101)
  • 2 × 6 mL presentation

High-volume 2 × 6 mL format for hemophilia treatment centers. 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 120 Tests
  • Reference Material: FVIII:C International Standard

Product Components

  • R1: 2 x 6 mL Human FX , lyophilized.
  • R2: 2 x 6 mL Activation Reagent, lyophilized.
  • R3: 2 x 6 mL Chromogenic Substrate specific for FXa (SXa-11), lyophilized.
  • R4+: 4 x 25 mL of Tris-BSA Buffer, ready to use.
  

Product Applications

Diagnosis of congenital or acquired Factor VIII:C deficiencies (Haemophilia A). Assay of Factor VIII:C activity, in citrated human plasma or in therapeutic concentrates, where Factor VIII:C activity must be measured. Follow-up of Factor VIII:C recovery in treated patients.

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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