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Rapid test tablets for Dengue Fever - Taiwan Registration c06cc7845287f86c38814d6af8f60f69

Access comprehensive regulatory information for Rapid test tablets for Dengue Fever in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c06cc7845287f86c38814d6af8f60f69 and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is CREATIVE LIFE SCIENCE CO., LTD..

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c06cc7845287f86c38814d6af8f60f69
Registration Details
Taiwan FDA Registration: c06cc7845287f86c38814d6af8f60f69
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Device Details

Rapid test tablets for Dengue Fever
TW: ้€Ÿๅพ—็™พๆฃฎ็™ป้ฉ็†ฑNS1ๆŠ—ๅŽŸๅฟซ้€Ÿๆธฌ่ฉฆ็‰‡
Risk Class 2

Registration Details

c06cc7845287f86c38814d6af8f60f69

DHA05603522405

Company Information

Korea, Republic of

Product Details

This product is used by immunofluorescence analysis with STANDARD F200 analyzer to detect dengue virus NS1 antigen in human serum and plasma. This test is used for in vitro professional diagnosis and assistance in the early diagnosis of dengue virus infection.

C Immunology and microbiology

C.0002 ็™ป้ฉ็†ฑ็—…ๆฏ’่ก€ๆธ…่ฉฆๅŠ‘

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Mar 07, 2022

Mar 07, 2027