Taiwan FDA registration 8422e80054969c8ef9ab307729d4705b

Up to fast prostate specific antigen rapid screening

TW: 達快攝護腺特異抗原快篩
Taiwan flagTaiwan·Risk Class 2·DIALAB PRODUCTION AND DISTRIBUTION OF CHEMICAL-TECHNICAL PRODUCTS AND LABORATORY INSTRUMENTS GESELLSCHAFT M.B.H.·Registered Dec 13, 2021 – Dec 13, 2026Active
Registration details
Analysis ID
8422e80054969c8ef9ab307729d4705b
Customs Code
DHA05603492007
Company information
Manufacturer Country
Austria
Authorized Representative
KS-HONG Biotech Co., Ltd
Product details
Intended Use
Chromatographic immunoassay was used to semi-quantitatively detect Prostatic specific antigen (PSA) in human serum and plasma.
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
Input;; QMS/QSD
Dates and status
Registration Date
Dec 13, 2021
Expiry Date
Dec 13, 2026
About this record

Access comprehensive regulatory information for Up to fast prostate specific antigen rapid screening in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8422e80054969c8ef9ab307729d4705b and manufactured by DIALAB PRODUCTION AND DISTRIBUTION OF CHEMICAL-TECHNICAL PRODUCTS AND LABORATORY INSTRUMENTS GESELLSCHAFT M.B.H.. The authorized representative in Taiwan is KS-HONG Biotech Co., Ltd.

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