Taiwan FDA registration 311c6d989ca2cec3688b18903bae53ee

Desilin Helicobacter pylori fecal antigen test kit (non-sterilized)

TW: 戴思林幽門桿菌糞便抗原測試劑組 (未滅菌)

Taiwan·Risk Class 1·DIASORIN INC.·Registered Sep 30, 2024 – Sep 30, 2029Active

Registration details

Analysis ID: 311c6d989ca2cec3688b18903bae53ee
Customs Code: DHA09402361804

Company information

Manufacturer: DIASORIN INC.
Manufacturer Country: United States
Authorized Representative: EVERLIGHT BIOTECH(TAIWAN) CO., LTD.

Product details

Intended Use: It is limited to the first-level identification scope of the "Helicobacter Serum Reagent (C.0003)" of the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.0003 螺旋桿菌屬血清試劑
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Sep 30, 2024
Expiry Date: Sep 30, 2029

About this record

Access comprehensive regulatory information for Desilin Helicobacter pylori fecal antigen test kit (non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 311c6d989ca2cec3688b18903bae53ee and manufactured by DIASORIN INC.. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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