Taiwan FDA registration 1981d874186a7ea6b75f631743aa0e8a

"Dirk" Helicobacter pylori antigen enzyme immunoassay reagent (unsterilized)

TW: "德克"幽門螺旋桿菌抗原酵素免疫檢測試劑 (未滅菌)

Taiwan·Risk Class 1·TAIWAN ADVANCED NANOTECH INC.·Registered Feb 24, 2015 – Feb 24, 2020Cancelled

Registration details

Analysis ID: 1981d874186a7ea6b75f631743aa0e8a

Company information

Manufacturer: TAIWAN ADVANCED NANOTECH INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: REININGHUN DIAGNOSTICS BIOMEDICAL CORPORATION

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
Product Type (Level 2): C.0003 螺旋桿菌屬血清試劑
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Feb 24, 2015
Expiry Date: Feb 24, 2020
Cancellation Date: Jun 16, 2022

Cancellation information

Status: Logged out
Reason: 自行鍵入

About this record

Access comprehensive regulatory information for "Dirk" Helicobacter pylori antigen enzyme immunoassay reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 1981d874186a7ea6b75f631743aa0e8a and manufactured by TAIWAN ADVANCED NANOTECH INC.. The authorized representative in Taiwan is REININGHUN DIAGNOSTICS BIOMEDICAL CORPORATION.

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