Taiwan FDA registration 11a3fd884f0cf8b0f9281292027fc83c

CITEST H. pylori Antigen Rapid Test Cassette(Non-Sterile)

TW: 創安幽門螺旋桿菌快速檢驗試劑(未滅菌)

Taiwan·Risk Class 1·MD·CITEST DIAGNOSTICS INC.·Registered Sep 10, 2019 – Sep 10, 2024Expired

Registration details

Analysis ID: 11a3fd884f0cf8b0f9281292027fc83c
License Form: Ministry of Health Medical Device Import No. 020845
Customs Code: DHA09402084500

Company information

Manufacturer: CITEST DIAGNOSTICS INC.
Manufacturer Country: Canada
Authorized Representative: Chuang An Biomedical Co., Ltd.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C0003 Helicobacter serological reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Sep 10, 2019
Expiry Date: Sep 10, 2024

About this record

Access comprehensive regulatory information for CITEST H. pylori Antigen Rapid Test Cassette(Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 11a3fd884f0cf8b0f9281292027fc83c and manufactured by CITEST DIAGNOSTICS INC.. The authorized representative in Taiwan is Chuang An Biomedical Co., Ltd..

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