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Up to fast prostate specific antigen rapid screening - Taiwan Registration 8422e80054969c8ef9ab307729d4705b

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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8422e80054969c8ef9ab307729d4705b
Registration Details
Taiwan FDA Registration: 8422e80054969c8ef9ab307729d4705b
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Device Details

Up to fast prostate specific antigen rapid screening
TW: ้”ๅฟซๆ”่ญท่…บ็‰น็•ฐๆŠ—ๅŽŸๅฟซ็ฏฉ
Risk Class 2

Registration Details

8422e80054969c8ef9ab307729d4705b

DHA05603492007

Product Details

Chromatographic immunoassay was used to semi-quantitatively detect Prostatic specific antigen (PSA) in human serum and plasma.

C Immunology and microbiology

C.6010 ่…ซ็˜ค็›ธ้—œๆŠ—ๅŽŸๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

Input;; QMS/QSD

Dates and Status

Dec 13, 2021

Dec 13, 2026