Taiwan FDA registration 5c05bebbeb6e7fb21b1ddd7f2b9d50a1

Reagent for the detection of aldehyde lipoalcohols

TW: 禮雅尚醛類脂醇檢驗試劑

Taiwan·Risk Class 2·DIASORIN INC.·Registered Dec 19, 2018 – Dec 19, 2028Active

Registration details

Analysis ID: 5c05bebbeb6e7fb21b1ddd7f2b9d50a1
Customs Code: DHA05603198303

Company information

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

Product details

Intended Use: This product uses chemical cold light immunoassay (CLIA) technology to quantitatively determine aldehyde lipoalcohols in human serological samples, ethylenediaminetetraacetic acid (EDTA) plasma samples, and processed urine samples. This product requires the use of Reich Series analyzers to perform the test analysis.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1045 醛固酮試驗系統;; A.1660 Quality Material (Analysis Only)
Import Information: import

Dates and status

Registration Date: Dec 19, 2018
Expiry Date: Dec 19, 2028

About this record

Access comprehensive regulatory information for Reagent for the detection of aldehyde lipoalcohols in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5c05bebbeb6e7fb21b1ddd7f2b9d50a1 and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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