BÜHLMANN fCAL® ELISA - FDA Cleared - Fecal Calprotectin - IBD - IBS

BÜHLMANN fCAL® ELISA (calprotectin)

BÜHLMANN fCAL® ELISA
BÜHLMANN fCAL® ELISA (K181012): FDA 510(k) cleared.
For in vitro Diagnostic Use.
CPT Code: Calprotectin – 83993

fecal Calprotectin (fCAL)- An FDA Cleared Gastrointestinal Test to Distinguish IBD from IBS

Calprotectin is a highly-sensitive clinical biomarker that has been shown to be extremely useful as an aid in diagnosis of inflammatory diseases in the gastrointestinal tract.

The BÜHLMANN fCAL® ELISA is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin in human stool. The BÜHLMANN fCAL®  ELISA aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.

This FDA 510k cleared, non-invasive, sensitive and specific assay is accurate, precise, efficient and offers reliable information to aid clinicians in selecting patients for further diagnostic procedures.

Product Information

Name BÜHLMANN fCAL® ELISA 
Method ELISA
Time to result 2 h (approx.)
Sample type 50-150 µl feces extract
Standard range 30-1800 µg/g
Sensitivity (LoQ) 30 µg/g
Instructions for Use & Other Downloads  see below

Because Accuracy is What Matters

  • Robust: accurate, precise & efficient assay to instill confidence
  • Validated:  in use worldwide providing over 1 million reliable patient results a year
  • Published: highly referenced, >75 peer reviewed scientific articles

CLINICIANS
Learn about the benefits of the BÜHLMANN fCAL® ELISA for your patients.

LABORATORY
Learn about the performance of the BÜHLMANN fCAL® ELISA

Learn More

Clinicians

The BÜHLMANN fCAL® ELISA sets a new standard in the industry:

A clinical study with a total of 337 adult and pediatric patients was performed to assess the ability of the BÜHLMANN fCAL® ELISA to discriminate between patients with IBD and other non-inflammatory GI disorders, including IBS.

 

  • Excellent sensitivity at cut-off of 80 ug/g of 93.3%: avoid false negatives in IBD/IBS screening!
  • Clinically proven, stable and consistent standardization since 2006
  • Narrow clinical grey zone between 80ug/g and 160ug/g
  • The only global assay with IVD registrations in the US (FDA), Canada (HC), Europe (CE-IVD), Japan (PMDA), China (SFDA), Australia (TGA), Brazil (ANVISA) etc.

Laboratory

 Precision and Reproducibility

Linearity

VISIT WEBSITE

http://calprotectinassays.com

 Download IFU and Catalog Numbers‡

View the appropriate tab below and click on the blue underlined catalog number to view the Instructions for Use.

U.S. Customers

BÜHLMANN fCAL® ELISA – EK-CAL

ELISA Kit Sizes: EK-CAL: 96 wells (1 plate), EK-CAL2: 192 tests (2 plate)

ROW

BÜHLMANN Products are distributed in Canada by Inter Medico.  For more information, email info@inter-medico.com or call 1.800.387.9643.

BÜHLMANN fCAL®ELISA – EK-CAL /CAL2 

ELISA Kit Sizes: EK-CAL: 96 wells (1 plate), EK-CAL2: 192 tests (2 plate),EK-CAL2-WEX: 192 tests (without extraction buffer for use with CALEX®)

Extraction Device:

CALEX® Cap Device – B-CALEX-C50/ B-CALEX-C200/ B-CALEX-C500

Extraction Kit for BÜHLMANN fCAL® assays B-CAL-EX3-EX12 

Watch Calprotectin Video (CDHF)

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