Taiwan FDA registration 1e14ba7313e3ce329edcff61f2408e86

"Randox" Immunoassay Speciality I Control

TW: "瑞德士"特殊免疫品管液

Taiwan·Risk Class 2·MD·RANDOX LABORATORIES LTD·Registered Jun 08, 2020 – Jun 08, 2025Expired

Registration details

Analysis ID: 1e14ba7313e3ce329edcff61f2408e86
License Form: Ministry of Health Medical Device Import No. 033489
Customs Code: DHA05603348905

Company information

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

Product details

Intended Use: This product is used in vitro diagnostics as a quality control control of immunoassay accuracy on clinical biochemical systems to monitor the accuracy and reproducibility of immunoassays.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1660 Quality Control Materials (Analytical and Non-Analytical)
Import Information: Imported from abroad

Dates and status

Registration Date: Jun 08, 2020
Expiry Date: Jun 08, 2025

About this record

Access comprehensive regulatory information for "Randox" Immunoassay Speciality I Control in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1e14ba7313e3ce329edcff61f2408e86 and manufactured by RANDOX LABORATORIES LTD. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..

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