Apex new generation hepatitis B surface antigen qualitative and confirmatory test set
Taiwan·Risk Class 3·ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Oct 19, 2022 – Oct 19, 2027Active- Analysis ID
- 6d453964a611ae96f5cf31812007b00a
- Customs Code
- DHA05603586708
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Manufacturer Country
- Ireland
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
- Intended Use
- 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.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests
- Import Information
- QMS/QSD;; 輸入
- Registration Date
- Oct 19, 2022
- Expiry Date
- Oct 19, 2027
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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