BIOPHEN™ FVIII:C hromogēnais tests (2 × 6 ml)
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BIOPHEN™ FVIII:C hromogēnais tests (2 × 6 ml)

Code: A221406-RUO
Manufacturer’s Part Number: 221406-RUO
Product size: 2 x 6 mL
Atļauja: RUO

Price: $965.00

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Produkta apraksts

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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.

Produkta raksturlielumi

  • 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%
  • Analīzes iekšējais koeficients (CV): 3–5 %
  • Analīžu starpā novērotā variācijas koeficients (CV): 4–7 %
  • Number of Tests (Manual Microplate Method): 2 x 120 Tests
  • Reference Material: FVIII:C International Standard

Produkta sastāvdaļas

  • 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.

Produkta pielietojuma jomas

For the measurement of Factor VIII:C in research applications.

Ir pieejami attiecīgie kalibratori un kontroles paraugi: BIOPHEN™ plazmas kalibrators (Ref. A222101-RUO), BIOPHEN™ normāla kontroles plazma (Ref. A223201-RUO) un BIOPHEN™ patoloģiska kontroles plazma (Ref. A223301-RUO).

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