5-PLASMA Bivalirudin AMR Verification Kit
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5-PLASMA Bivalirudin AMR Verification Kit

Code: A5D-45905
Manufacturer’s Part Number: 5D-45905
Product size: Kit
Clearance: 510(k)
Price: $400.00
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Product Description

The 5-PLASMA Bivalirudin AMR Verification Kit consists of lyophilized human plasma spiked with defined concentrations of bivalirudin for verifying the Analytical Measurement Range (AMR) of anti-IIa clotting and chromogenic bivalirudin assay systems. Five evenly distributed reference levels span the calibration curve from 0.5 to 4.5 µg/mL, enabling linearity studies, reportable range determination, and analytical method validation across the full measurement range.

Each kit contains lyophilized human plasma with stabilizing agents.

Product Characteristics

  • Human plasma matrix consistent with calibrators and controls throughout the complete assay system
  • Lyophilized format for extended stability and reproducibility
  • Designed for AMR verification, linearity assessment, and analytical method validation
  • Five evenly distributed levels spanning the full assay range (0.5 – 4.5 µg/mL)
  • Compatible with anti-IIa clotting and chromogenic bivalirudin assay platforms
  • Lot-specific assigned values provided with each kit

Product Components

  

Product Applications

Manufactured by 5-Diagnostics and optimized specifically for bivalirudin assay methods, the matched human plasma matrix ensures consistent linearity throughout the Analytical Measurement Range (AMR) verification. When used alongside the 5-PLASMA Bivalirudin Calibrator (5D-46905) and 5-PLASMA Bivalirudin Control (5D-44905), these analytes complete a bivalirudin assay system.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents