Chembio Procise IFX Assay Infliximab

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