Taiwan FDA registration 593cf31015f0a1505a1b1682cd96fcb3
Abbott Alinity c ASO Standard
TW: 亞培抗鏈球菌溶血素O標準液
Taiwan·Risk Class 2·MD·BIOKIT S.A.·Registered Oct 31, 2019 – Oct 31, 2024ExpiredRegistration details
- Analysis ID
- 593cf31015f0a1505a1b1682cd96fcb3
- License Form
- Ministry of Health Medical Device Import No. 032955
- Customs Code
- DHA05603295503
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 establish the calibration curve of the "Apbot" antistreptolysin O test set (unsterilized) on the Alinity c analyzer by turbidimetry. This product should be used with the "Apbot" antistreptolysin O test kit (unsterilized).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1150 calibrate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 31, 2019
- Expiry Date
- Oct 31, 2024
About this record
Access comprehensive regulatory information for Abbott Alinity c ASO Standard in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 593cf31015f0a1505a1b1682cd96fcb3 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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