5-PLASMA Bivalirudin Calibrator
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5-PLASMA Bivalirudin Calibrator

Code: A5D-46905
Manufacturer’s Part Number: 5D-46905
Product size: Kit
Clearance: 510(k)
Price: $350.00
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Product Description

The 5-PLASMA Bivalirudin Calibrator consists of lyophilized human plasmas spiked with defined concentrations of bivalirudin for establishing a calibration curve in anti-IIa clotting and chromogenic bivalirudin assay systems. The five-level kit spans 0.0 to 5.0 µg/mL - Calibrators 1 through 5 -supporting accurate curve generation, linearity assessment, and lot-to-lot traceability across the full assay measurement range.

Each kit contains lyophilized human plasma with stabilizing agents.

Product Characteristics

  • Human plasma matrix consistent with controls and AMR kit throughout the complete assay system
  • Lyophilized format for extended stability and reproducibility
  • Five-point calibration spanning the full assay measurement range (0.00-5.00 µg/mL)
  • Compatible with anti-IIa clotting and chromogenic bivalirudin assay platforms
  • Lot-specific assigned values provided with each kit

Product Components

  • Calibrator 1 (Cal 1): ≈ 0.0 µg/mL bivalirudin, 2 vials/kit
  • Calibrator 2 (Cal 2): ≈ 1.0 µg/mL bivalirudin, 2 vials/kit
  • Calibrator 3 (Cal 3): ≈ 2.0 µg/mL bivalirudin, 2 vials/kit
  • Calibrator 4 (Cal 4): ≈ 3.5 µg/mL bivalirudin, 2 vials/kit
  • Calibrator 5 (Cal 5): ≈ 5.0 µg/mL bivalirudin, 2 vials/kit
  • Concentrations may vary slightly between lots. Refer to lot-specific documentation for assigned values.
  

Product Applications

Manufactured by 5-Diagnostics and optimized specifically for bivalirudin assay methods, the matched human plasma matrix ensures consistency from calibration through quality control. When used alongside the 5-PLASMA Bivalirudin Control (5D-44905) and 5-PLASMA Bivalirudin AMR Verification Kit (5D-45905), these calibrators complete bivalirudin assay system.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents