New Health Canada Licences: Quantum Blue® Infliximab Assay, IBDoc®,CALEX® Cap

BUHLMANN Diagnostics Corp (BDC), BÜHLMANN Laboratories AG’s North American affiliate is proud to announce that three of its novel products, Quantum Blue® Infliximab Assay, IBDoc® and CALEX®Cap have received Medical Device Licences from Health Canada and are now commercially available in Canada. Quantum Blue® Infliximab® and CALEX® CAP devices were approved as Class II medical devices according to the Canadian Medical Device Regulations. IBDoc® was approved as a Class III medical device.

Quantum Blue® Infliximab

Rapid and Quantitative Lateral Flow Assay for Infliximab
Health Canada Licence: 98838

Assay Advantages:

  • Fast: 15 min to quantitative results
  • Ideal Measuring Range: 0.4- 20 µg/ml range
  • Correlates well with standard ELISAs for determination of infliximab
  • Quantum Blue® Trusted routine platform

 

Quantum Blue® Infliximab is for Research Use Only in the US.  Not for use in diagnostic procedures.

IBDoc®

Three Easy Steps to Calprotectin Self Testing
Health Canada License: 98903

Assay Advantages:

  • Simple & Fast: Easy 3 step procedure, 12 min to quantitative result
  • Convenient: CALEX® Valve offers simple and easy-to-handle stool extraction
  • Efficient & More Frequent Testing: Results can be automatically transmitted and shared electronically

IBDoc® is not available for sale in the US.

CALEX® Cap

Rapid, Clean, Consistent and Safe Sample Preparation
Health Canada License: 98839

Assay Advantages:

  • Fast: Stool extraction within 10 min
  • Efficient: Optimal dilution yields maximum extraction
  • Reliable & Precise: High correlation to gold standard manual extraction
  • Prefilled primary tube for all BÜHLMANN fCAL® assays

CALEX® Cap is for Research Use Only in the US.  Not for use in diagnostic procedures.

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