BÜHLMANN launched its first fecal calprotectin assay over 10 years ago and since then has developed into THE CALPROTECTIN COMPANY with the highest quality standards. The offerings include the FDA 510(k) cleared BÜHLMANN fCAL® ELISA, the FDA 510(k) cleared automated BÜHLMANN fCAL® turbo (in combination with CALEX® Cap fecal extraction device) for testing on most clinical chemistry analyzers, the Quantum Blue® fCAL rapid test and IBDoc®, the first self-testing device for fecal calprotectin in IBD patients. This assay portfolio provides a range of solutions servicing all types of users, from the subject’s home test to the high throughput labs running thousands of samples.
We are proud to celebrate BÜHLMANN’s calprotectin products now appear in more than 100 peer reviewed publications!
BÜHLMANN fCAL® turbo (K190784): FDA 510(k) cleared: For in vitro Diagnostic Use.
BÜHLMANN fCAL® turbo + CALEX® Cap (191718): FDA 510(k) cleared. For in vitro Diagnostic Use.
BÜHLMANN fCAL® ELISA (K181012): FDA 510(k) cleared. For in vitro Diagnostic Use.
(fCAL are for Research Use Only. Not for use in diagnostic procedures in the US.)
IBDoc® is not available for sale in the US.
Heath Canada Licences:
BÜHLMANN fCAL® turbo: 96808
BÜHLMANN fCAL® ELISA: 80726
Quantum Blue ® fCAL: 83477
Quantum Blue ® fCAL extended:100161
BÜHLMANN CALEX® Cap: 98839
IBDoc® Cap: 98903, Device class: 3