Taiwan FDA registration 6eead68bf19839a71434b7fff200e680

"Ximenzi" Hepatitis B e Anti-體檢驗試劑組

TW: "西門子" B型肝炎 e 抗體檢驗試劑組

Taiwan·Risk Class 3·BIOKIT S.A.;; Siemens Healthcare Diagnostics Inc.·Registered Nov 19, 2024 – Nov 19, 2029Active

Registration details

Analysis ID: 6eead68bf19839a71434b7fff200e680
Customs Code: DHA05603751500

Company information

Manufacturer: BIOKIT S.A.;; Siemens Healthcare Diagnostics Inc.
Manufacturer Country: Spain;;United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: This product is used for in vitro diagnostics and can be used with the Atellica IM analyzer to qualitatively detect antibodies to HBV e antigen in human (over 2 years old) serum, EDTA plasma or lithium heparin plasma in patients with signs or symptoms of hepatitis B infection, or who are at risk of hepatitis B virus (HBV) infection, or who are known to be infected with HBV. Test results, along with other diagnostic information, can be used to assist in determining the clinical status of HBV or in the management of HBV disease.
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); B.4020 Analysis of specific tests
Import Information: 委託製造;; QMS/QSD;; 輸入

Dates and status

Registration Date: Nov 19, 2024
Expiry Date: Nov 19, 2029

About this record

Access comprehensive regulatory information for "Ximenzi" Hepatitis B e Anti-體檢驗試劑組 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 6eead68bf19839a71434b7fff200e680 and manufactured by BIOKIT S.A.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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