|May 2022 Amber PETG 5ml (and 10ml) change due to ongoing supply disruptions and shortage of material/ supplier capacity.|
April 2022 White PP Cap temp color change due to ongoing supply disruptions and shortage of material/ supplier capacity.
March 2022 Clear PETG vial change due to ongoing supply disruptions and shortage of material/ supplier capacity.
Jan 2022 Amber PETG 10ml vial and cap change due to ongoing supply disruptions and shortage of material/ supplier capacity.
June 2021 PETG 5ml vial change to glass due to pandemic and shortage of material/ supplier capacity as government contracts for the manufacturing of vaccine vials take priority.
June 2021 CK-MB ELISA kits have had wash steps increased from three (3) to five (5) in order to reduce background noise and improve product performance.
Sept 2020 conference organizers have cancelled in-person exhibitions for MEDICA (Nov 2020) and AACC (Dec 2020) due to ongoing corona virus pandemic.
May 2020 PAPP-A ELISA and CLIA kits have been improved with antibody-plate to eliminate any biotin related interference. As such one step is removed. All other aspects unchanged, please see updated IFU on product page.
Sept 2019 N-T4 ELISA kits have been improved with Streptavidin plate and a Working N-T4 Biotin Reagent will be used as the extraction buffer. All other aspects unchanged, please see updated IFU on product page.
May 2019 Cortisol, Testosterone, 17OHP, 170HP-SI ELISA and CLIA kits have been improved with ready-to-use Enzyme and Tracer Reagent. Steroid Conjugate Buffer will no longer be included in the products, therefore the mixing step is eliminated. Please see updated IFU in product insert page.
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.
Dec 2018 Free Testosterone ELISA and CLIA kits improved larger measurement range, three-level control and antibody-plate. See product page for more details.
Oct 2018 Free beta hCG ELISA and CLIA kits replaced with new version/ product number with mass units with shorter procedure. See product page for more details.
Sept 2018 PAPP-A ELISA and CLIA kits replaced with new version/ product number with mass units with shorter procedure. See product page for more details.
Jan 2018 Vitamin D Direct ELISA and CLIA kits will now contain a two-level control
Dec 2017 Biotin Interference response to FDA notice and instruction on how much biotin is acceptable and when to collect patient samples
July 2017 Announcing MONOKIT a new brand launched by Monobind
June 2017 N-17OHP ELISA has Improved Performance through new assay procedure that boosts sensitivity and precision. See updated IFU for details.
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 2016 Free 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 2014 High-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 2014 Releasing & Stabilizing Agents, used in Folate, Vit B12 and Anemia VAST kits, volumes increased to provide labs with more reagents, see Advisory Notice|
| May 2013 Neutralization Buffer reagent used in Vitamin B12 and Folate assays modified with red color for better ease of use, see Advisory Notice|
| June 2012 Tg improved with ready-to-use enzyme reagent, new IFU with dramatically reduced assay time. The test has also been restandardized to ensure agreement with the established international standard.|
|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|
|October 2010 Digoxin changed to HRP system|
| June 2010 Progesterone improved with ready-to-use enzyme reagent, new IFU|
| December 2009 CEA introduced in Next Generation|
|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.|