Taiwan FDA registration 75939b63352d04966be16cf2b1c1cca4

Regal Son Calprotectin Test Set

TW: 禮雅尚鈣衛蛋白檢驗試劑組

Taiwan·Risk Class 2·DIASORIN INC.·Registered Aug 19, 2020 – Aug 19, 2025Expired

Registration details

Analysis ID: 75939b63352d04966be16cf2b1c1cca4
Customs Code: DHA05603353104

Company information

Manufacturer: DIASORIN INC.
Manufacturer Country: United States
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.5180 Fecal Calcium Protein Immunoassay System;; A.1660 Quality control materials (analytical and non-analytical)
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Aug 19, 2020
Expiry Date: Aug 19, 2025

About this record

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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