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 2 medical devices according to the Canadian Medical Device Regulations. IBDoc® was approved as a Class 3 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.
