BIOPHEN™ DTI (Direct Thrombin Inhibitors)
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BIOPHEN™ DTI (Direct Thrombin Inhibitors)

Code: A220202-RUO
Manufacturer’s Part Number: 220202
Product size: 2 x 2.5 mL
Clearance: RUO
Price: $455.00
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Product Description

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

BIOPHEN™ DTI is a chromogenic anti-IIa assay for quantitative measurement of direct thrombin inhibitors — dabigatran (PradaxaŽ) and bivalirudin (AngiomaxŽ) — in human citrated plasma. Method: Patient plasma + excess human ?-thrombin (R1) ? DTI inhibits thrombin ? residual thrombin measured with chromogenic substrate (R2). For therapeutic drug monitoring, emergency quantification (ER/pre-surgery), and pharmacokinetic studies. Calibrate with Dabigatran Calibrator (222801) or Bivalirudin Calibrator (222901). Controls: Dabigatran Control (224701) + Dabigatran Control Low (225001), or DTI Control (SC030K). CE-IVD.

Product Characteristics

  • Total Assay Time: ≤ 10 min
  • Detection Threshold:
      High Range (Hirudin): 0.30 Âľg/mL
      Low Range (Hirudin): 0.15 Âľg/mL
      Standard Range (Dabigatran): 14.6 ng/mL
      Low Range (Dabigatran): 6.3 ng/mL
  • Dynamic Range:
      High Range (Hirudin): 0 to 5 Âľg/mL
      Low Range (Hirudin): 0 to 2 Âľg/mL
      Standard Range (Dabigatran): 0 to 500 ng/mL
      Low Range (Dabigatran): 0 to 120 ng/mL
  • Intra-Assay CV: < 5%
  • Inter-Assay CV: < 5%
  • Number of Tests (Manual Method): 2 x 10 Tests

Product Components

  • R1: 2 x 2.5 mL Thrombin chromogenic substrate, lyophilized.
  • R2: 2 x 2.5 mL human Thrombin, lyophilized.
  • R3: 2 x 25 mL of Tris-BSA Buffer, ready to use.
  

Product Applications

For the measurement of direct thrombin inhibitors in research applications.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents

  

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