Calibration solution and quality control solution of apex lipoprotein (a) test reagent group
Taiwan·Risk Class 2·BIOKIT S.A.·Registered Jan 07, 2022 – Jan 07, 2027Active- Analysis ID
- 85300c78b0cb88d73ab32a826987f4f6
- Customs Code
- DHA05603520106
- Manufacturer
- BIOKIT S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
- Intended Use
- Calibration solution: This product is used to establish the calibration curve of the "Apepeth" lipoprotein (a) detection kit (unsterilized) on the ARCHITECT c system by turbidimetric method. Quality control solution: This product quality control solution I and quality control solution II are used as analytical quality management materials when quantitatively monitoring lipoprotein (a) by turbidimetric method with "APE" lipoprotein (a) test set (unsterilized) on the ARCHITECT c system.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
- Import Information
- QMS/QSD;; 輸入
- Registration Date
- Jan 07, 2022
- Expiry Date
- Jan 07, 2027
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Access comprehensive regulatory information for Calibration solution and quality control solution of apex lipoprotein (a) test reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 85300c78b0cb88d73ab32a826987f4f6 and manufactured by BIOKIT S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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