MBL Obtained European Quality Management System Certificate (IVDR)

Medical and Biological Laboratories Co., Ltd. (President: Kimimasa Yamada), a JSR Life Sciences company, announced today that it has received its “EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Device Regulation (IVDR). The certification ensures that the CE marked diagnostic products supplied by MBL adhere to standards of quality and safety that ensure the highest level of patients’ health protection. 

IVDR certification is granted by the European Commission to products and organizations that have been approved reviewed and found to be in compliance with the In Vitro Diagnostics Regulation (IVDR), the latest regulation for in vitro diagnostic medical devices in the EU for product safety and efficacy. With IVDR certification MBL will be able to display the CE mark on product packaging and continue to expand the products it supplies within the EU. 

The IVDR certification applies to the following products:

• MESACUP BP180 TEST 
• MESACUP BP230 TEST
• MESACUP-2 TEST Desmoglein 1
• MESACUP-2 TEST Desmoglein 3”

The MESACUP tests measureskin-specific autoantibodies in serum by *ELISA. By identifying and measuring autoantibodies, it is used as an aid in the diagnosis of autoimmune bullous disease(pemphigus, pemphigoid), a skin-specific autoimmune disease, and for the monitoring of the response to therapy for treatment.

• HEXAMATE Factor XIII 
• HEXAMATE Factor XIII – Calibrator
• HEXAMATE Factor XIII – Control I/II

The HEXAMATE line of products are reagents for measuring coagulation factor XIII in plasma by latex immunoturbidimetry and aid in the diagnosis of factor XIII deficiency. 

*ELISA: Enzyme-Linked Immunosorbent Assay