Taiwan FDA registration aa473067e77ace96a160d9cd2bf1024d

Regalishang pylori IgG antibody-quality control solution

TW: 禮雅尚幽門桿菌IgG抗體-品管液

Taiwan·Risk Class 2·DIASORIN INC.·Registered Mar 09, 2022 – Mar 09, 2027Active

Registration details

Analysis ID: aa473067e77ace96a160d9cd2bf1024d
Customs Code: DHA05603522507

Company information

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

Product details

Intended Use: This product is used to monitor the performance of the Reichan pylori IgG assay. The performance characteristics of this product in connection with other test items or instrument platforms different from the Reich Analyzer and the Reich XL Analyzer have not been established.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Mar 09, 2022
Expiry Date: Mar 09, 2027

About this record

Access comprehensive regulatory information for Regalishang pylori IgG antibody-quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number aa473067e77ace96a160d9cd2bf1024d and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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