Jan 2019 cTnI ELISA and CLIA kits have been improved and re-calibrated for better low-end discrimination with a lower
cutoff/ expected range (<0.4 ng/ml vs <1.3) as well as an antibody-coated plate. See product page for updated IFU.
August 2016 Lumax instruments require setting update (version K), or new EPROM (version I or earlier) to accommodate changes in TSH CLIA Tracer which produces greater light output for more assay sensitivity.
May 2016 T4 ELISA Enzyme and CLIA Tracer packaging updated in all T4, FT4, Thyroid VAST, Free Thyroid VAST, and NT4 Kits from clear to amber vial as a better safeguard against reagent light sensitivity.
March 2016 Anti-H. Pylori IgM enzyme reagent has changed color from purple to teal due to a new buffer. All other aspects unchanged, including procedure and performance. See Advisory Notice.
February 2016Free beta hCG replaced by Extended Range product In order to have a more competitive product offering, especially in the area of prenatal testing, Monobind has introduced a new product.
November 2014High-protein patient samples used in Folate, Vit B12 and Anemia VAST kits, should first be diluted 1:1 in a saline solution before performing Sample Extraction. See updated IFUs and Folate & Vit B12 Extraction Step Guide
July 2014Releasing & Stabilizing Agents, used in Folate, Vit B12 and Anemia VAST kits, volumes increased to provide labs with more reagents, see Advisory Notice
May 2013Neutralization Buffer reagent used in Vitamin B12 and Folate assays modified with red color for better ease of use, see Advisory Notice
October 2011 MONOBIND RECEIVES CE QUALITY CERTIFICATE FOR PSA PRODUCT FAMILY
has received a CE-Certificate for its complete PSA product family (consisting of Annex II List B Devices: PSA ELISA, PSA CLIA, Free PSA ELISA, Free PSA CLIA, Cancer VAST ELISA, Cancer VAST CLIA
March 2010 Best of Lake Forest Award in Medical Devices
Monobind among top 1.4% of companies selected two consecutive years for outstanding business award in its category demonstrating positive image and leadership in the community
August 2009 Rapid Insulin ELISA product introduced to cut incubation time in half
November 2008 MONOBIND RECEIVES ISO 13485:2003 STATUS
Certification ensures the satisfaction of harmonized international medical device standards within Monobind’s Quality Management System
December 2007 COUNTERFEIT MONOBIND TEST KITS
Advisory issued to distributors and end-users, beware of false, poor quality products bearing Monobind name they are not authentic.
