5-PLASMA Bivalirudin Control
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5-PLASMA Bivalirudin Control

Code: A5D-44905
Manufacturer’s Part Number: 5D-44905
Product size: Kit
Clearance: 510(k)
Price: $300.00
Qty
 

Product Description

The 5-PLASMA Bivalirudin Control consists of lyophilized human plasma spiked with defined concentration of bivalirudin for use as quality control material in anti-IIa clotting and chromogenic bivalirudin assay systems. The two-level design – Control 1 at approximately1.5 µg/mL and Control 2 at approximately 4.0 µg/mL – brackets the assay measurement range to support within-run precision assessment, between-run consistency monitoring, and assay performance verification.

Each kit contains lyophilized human plasma with stabilizing agents.

Product Characteristics

  • Human plasma matrix consistent with calibrators and AMR kit throughout the complete assay system
  • Lyophilized format for extended stability and reproducibility
  • Two-level design for within-run and between-run precision assessment
  • Compatible with anti-IIa clotting and chromogenic bivalirudin assay platforms
  • Lot-specific assigned values provided with each kit

Product Components

  • Control 1 (C1): ≈ 1.5 µg/mL bivalirudin, 3 vials/kit
  • Control 2 (C2): ≈ 4.0 µg/mL bivalirudin, 3 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 consistent performance throughout the analytical workflow. When used alongside the 5-PLASMA Bivalirudin Calibrator (5D-46905) and 5-PLASMA Bivalirudin AMR Verification Kit (5D-45905), these controls complete a bivalirudin assay system.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents