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Vitex biochemical products glycohemoglobin reagent group - Taiwan Registration 2d21a50c9f1d4726a9fa3a9a6853c3f5

Access comprehensive regulatory information for Vitex biochemical products glycohemoglobin reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2d21a50c9f1d4726a9fa3a9a6853c3f5 and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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2d21a50c9f1d4726a9fa3a9a6853c3f5
Registration Details
Taiwan FDA Registration: 2d21a50c9f1d4726a9fa3a9a6853c3f5
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Device Details

Vitex biochemical products glycohemoglobin reagent group
TW: ็ถญ็‰นๅธ็”ŸๅŒ–็”ขๅ“้†ฃๅŒ–่ก€่‰ฒ็ด ่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

2d21a50c9f1d4726a9fa3a9a6853c3f5

DHA05603242500

Company Information

United States

Product Details

This product is suitable for use with the VITROS 5, 1 FS Chemistry Analyzer, VITROS 4600 Chemistry Analyzer and VITROS 5600 Biochemical Immunoassay Analyzer for the quantitative determination of the proportion of glycohydrated hemoglobin in human whole blood, containing (DCCT/NGSP) and mmol/mol (IFCC).

B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.7470 Analysis of glycosylated hemoglobin

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Dates and Status

May 08, 2019

May 08, 2029