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Chembio Procise IFX Assay Infliximab
SDP

Catalog No. 21010243
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Catalog No. 21-010-243 Supplier Chembio Supplier No. 5385
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Description

Procise IFX™ Assay enables rapid, quantitative monitoring of infliximab in serum using the ProciseDx™ Analyzer, it supports IBD treatment decisions with results in under 5 minutes.

  • Quantitative TDM for Infliximab: Enables rapid measurement of infliximab levels in serum to support therapeutic management of IBD patients
  • Fast Results: Delivers accurate, quantitative results in under 5 minutes using the ProciseDx™ Analyzer
  • Validated for Clinical Use: FDA-cleared for use in moderate-complexity labs; supports both adult and pediatric Crohn's disease and ulcerative colitis care
  • Proven Analytical Performance: Sensitive and specific TR-FRET-based immunoassay with a reportable range of 1.2 to 50 μg/mL
  • Simple Workflow: Uses standard serum samples and minimal hands-on time

Specifications

Certifications/Compliance FDA DeNovo
Content And Storage 15°C to 30°C (59°F to 86°F)
Control Sets Included High and Low
CE Marker Yes
Clia Complexity Moderate (Prescription Use Only)
Detectable Analytes Infliximab
Detection Method Measures Relative Fluorescence Units (RFU)
DoA Calibrators No
Sample Type Serum
Type Test Cartridge
Disposable Single-use
For Use With (Equipment) ProciseDx Analyzer
Includes 20 Reagent Cartridges and Buffer Bulbs, 4 Controls a 2- High and 2- Low, Product Insert
Level High, Low
Quantity 20 Pk.
Range 1.2 to 50.0 μg/mL
Sample Size 20 μL
Analysis Time <5 minutes
Dimensions (L x W x H) 15 x 8 x 5.7 in.
Form Freeze-dried
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