Taiwan FDA registration 2d21a50c9f1d4726a9fa3a9a6853c3f5

Vitex biochemical products glycohemoglobin reagent group

TW: 維特司生化產品醣化血色素試劑組

Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.·Registered May 08, 2019 – May 08, 2029Active

Registration details

Analysis ID: 2d21a50c9f1d4726a9fa3a9a6853c3f5
Customs Code: DHA05603242500

Company information

Manufacturer: ORTHO-CLINICAL DIAGNOSTICS, INC.
Manufacturer Country: United States
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: 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).
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.7470 Analysis of glycosylated hemoglobin
Import Information: import

Dates and status

Registration Date: May 08, 2019
Expiry Date: May 08, 2029

About this record

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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