Taiwan FDA registration 99b8075dde94d52510880828dd09e403

Huayu-Tumor marker DR-70 enzyme immunoassay diagnostic reagent

TW: 華宇-腫瘤標記DR-70酵素免疫分析診斷試劑
Taiwan flagTaiwan·Risk Class 2·Shiji Biomedical Co., Ltd. Taipei Plant·Registered Jul 16, 2014 – Jul 16, 2029Active
Registration details
Analysis ID
99b8075dde94d52510880828dd09e403
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
UNI PHARMA CO., LTD.
Product details
Intended Use
The DR-70 assay can be used to determine the concentration of tumor marker (DR-70) in a patient's serum.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.6010 腫瘤相關抗原免疫試驗系統
Import Information
Contract manufacturing;; Domestic
Dates and status
Registration Date
Jul 16, 2014
Expiry Date
Jul 16, 2029
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About this record

Access comprehensive regulatory information for Huayu-Tumor marker DR-70 enzyme immunoassay diagnostic reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 99b8075dde94d52510880828dd09e403 and manufactured by Shiji Biomedical Co., Ltd. Taipei Plant. The authorized representative in Taiwan is UNI PHARMA CO., LTD..

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