Taiwan FDA registration 470cb8054f220b18c4b47de692c64ecf

Sistan Hepatitis C antibody rapid screening

TW: 詩丹C型肝炎抗體快篩

Taiwan·Risk Class 3·SD BIOSENSOR, INC.·Registered Dec 30, 2022 – Dec 30, 2027Active

Registration details

Analysis ID: 470cb8054f220b18c4b47de692c64ecf
Customs Code: DHA05603589602

Company information

Manufacturer: SD BIOSENSOR, INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: KS-HONG Biotech Co., Ltd

Product details

Intended Use: This product is a rapid immunochromatography method that can be used for qualitative detection of HCV-specific antibodies present in human serum, plasma or whole blood. This test is used for in vitro professional diagnostic purposes, and the purpose is to help patients with clinical symptoms of HCV infection to diagnose HCV infection early. It only provides preliminary screening results. More specific alternative diagnostic approaches should also be prescribed to confirm HCV infection. This product is not intended for self-testing.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Dec 30, 2022
Expiry Date: Dec 30, 2027

About this record

Access comprehensive regulatory information for Sistan Hepatitis C antibody rapid screening in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 470cb8054f220b18c4b47de692c64ecf and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is KS-HONG Biotech Co., Ltd.

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