Regal Son Calprotectin Test Set - Taiwan Registration 75939b63352d04966be16cf2b1c1cca4
Access comprehensive regulatory information for Regal Son Calprotectin Test Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 75939b63352d04966be16cf2b1c1cca4 and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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Device Details
Product Details
THIS PRODUCT IS USED FOR THE IN VITRO QUANTITATIVE DETECTION OF HUMAN FECAL CALPROTECTIN, A NEUTROPHIL GLOBULIN, ON LIAISON AND LIAISON XL ANALYZERS BY SANDWICH CHEMICAL COLD LIGHT IMMUNOASSAY (CLIA), WHICH CAN BE USED AS AN INDICATOR OF MUCOSAL INFLAMMATION. This product (Control Set) is designed to monitor the performance of the Regal Clinophilin test using quality management panel analysis. This product (Q.S.E.T. Buffer) is intended for use in the preparation of human stool samples for the purpose of performing tests in designated Dia Sorin stool analysis. This product (Q.S.E.T. Device) is intended for use in the preparation of human stool samples for the purpose of performing tests in designated Dia Sorin stool analysis.
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
C.5180 Fecal Calcium Protein Immunoassay System;; A.1660 Quality control materials (analytical and non-analytical)
Input;; QMS/QSD
Dates and Status
Aug 19, 2020
Aug 19, 2025