Taiwan FDA registration 447d82c70b3e33a163ff48fc9b003d62
Abbott ferritin/myoglobin/IgE quality control group
TW: 亞培儲鐵蛋白/肌紅蛋白/IgE品管液組
Taiwan·Risk Class 2·BIOKIT S.A.·Registered Dec 19, 2022 – Dec 19, 2027ActiveRegistration details
- Analysis ID
- 447d82c70b3e33a163ff48fc9b003d62
- Customs Code
- DHA05603589207
Company information
- Manufacturer
- BIOKIT S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used to monitor the quality management of the Api myoglobin test set and IgE analysis results obtained by turbidimetry. This product should be used with the Api Myoglobin Test Set and IgE Reagent on the Alinity c Analyzer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 19, 2022
- Expiry Date
- Dec 19, 2027
About this record
Access comprehensive regulatory information for Abbott ferritin/myoglobin/IgE quality control group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 447d82c70b3e33a163ff48fc9b003d62 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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