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Apex new generation hepatitis B surface antigen qualitative and confirmatory test set - Taiwan Registration 6d453964a611ae96f5cf31812007b00a

Access comprehensive regulatory information for Apex new generation hepatitis B surface antigen qualitative and confirmatory test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 6d453964a611ae96f5cf31812007b00a and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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6d453964a611ae96f5cf31812007b00a
Registration Details
Taiwan FDA Registration: 6d453964a611ae96f5cf31812007b00a
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Device Details

Apex new generation hepatitis B surface antigen qualitative and confirmatory test set
TW: ไบžๅŸนๆ–ฐไธ€ไปฃBๅž‹่‚็‚Ž่กจ้ขๆŠ—ๅŽŸๅฎšๆ€งๅŠ็ขบ่ชๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 3

Registration Details

6d453964a611ae96f5cf31812007b00a

DHA05603586708

Company Information

Product Details

This product is used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i system. This product is used to assist in the diagnosis of hepatitis B virus (HBV) infection and should not be used for blood donor screening.

B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Oct 19, 2022

Oct 19, 2027