Taiwan FDA registration 146a74b20dc1710c52022954b407fd0b
"Apbot" Lipolytic enzyme test set of correction solution and quality control solution
TW: “亞培” 脂肪分解酵素檢驗試劑組之校正液與品管液
Registration details
- Analysis ID
- 146a74b20dc1710c52022954b407fd0b
- Customs Code
- DHA05603312608
Company information
- Manufacturer
- SENTINEL CH. S.p.A.
- Manufacturer Country
- Italy
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Correction solution: This product can only be used to correct lipase NG. In vitro diagnostic use. Pipe solution 1, 2: This product can only be used to verify the performance of lipase NG.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 calibration;; A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- import
Dates and status
- Registration Date
- Jan 08, 2020
- Expiry Date
- Jan 08, 2030
About this record
Access comprehensive regulatory information for "Apbot" Lipolytic enzyme test set of correction solution and quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 146a74b20dc1710c52022954b407fd0b and manufactured by SENTINEL CH. S.p.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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