Taiwan FDA registration 6cde33d468280f42243bbb1a570e0036

"Retex" β-hydroxybutyric acid reagent

TW: "瑞德士" β-羥基丁酸試劑

Taiwan·Risk Class 2·RANDOX LABORATORIES LTD·Registered Jul 29, 2021 – Jul 29, 2026Expired

Registration details

Analysis ID: 6cde33d468280f42243bbb1a570e0036
Customs Code: DHA05603468000

Company information

Manufacturer: RANDOX LABORATORIES LTD
Manufacturer Country: United Kingdom
Authorized Representative: KUO'S YUAN IN ENTERPRISE CO., LTD.

Product details

Intended Use: For in vitro quantification of β-hydroxybutyric acid in serum and plasma. This product is suitable for use with RX monza analytical instruments.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1435 Trial (non-quantitative) strains;; A.1150 Calibrated Products
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Jul 29, 2021
Expiry Date: Jul 29, 2026

About this record

Access comprehensive regulatory information for "Retex" β-hydroxybutyric acid reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6cde33d468280f42243bbb1a570e0036 and manufactured by RANDOX LABORATORIES LTD. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..

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