Taiwan FDA registration 218c666b157187c93f2110a1523af0c8

Reek & Shang 25 hydroxy total vitamin D test reagent

TW: 禮雅尚25羥基總維生素D檢驗試劑

Taiwan·Risk Class 2·DIASORIN INC.·Registered Nov 16, 2018 – Nov 16, 2028Active

Registration details

Analysis ID: 218c666b157187c93f2110a1523af0c8
Customs Code: DHA05603179107

Company information

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

Product details

Intended Use: Efficacy (text revision) change: This product must be used with Liyashang series analyzers (Liyashang XL analyzer, Liyashang XS analyzer) to quantitatively determine 25 hydroxyvitamin D and other hydroxyvitamin D metabolites in human serum by chemical cold light immunoassay (CLIA) technology to evaluate vitamin D adequacy.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1825 Vitamin D testing system;; A.1660 Quality control materials (analytical and non-analytical); B.4010 Reaction Reagents for General Purposes
Import Information: import

Dates and status

Registration Date: Nov 16, 2018
Expiry Date: Nov 16, 2028

About this record

Access comprehensive regulatory information for Reek & Shang 25 hydroxy total vitamin D test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 218c666b157187c93f2110a1523af0c8 and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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