Taiwan FDA registration bef74d8335aa691c2ca40e84c0fea762
“Abbott” Lp(a) Reagent Kit (Non-Sterile)
TW: “亞培”脂蛋白(a)檢驗試劑組(未滅菌)
Taiwan·Risk Class 1·MD·BIOKIT S.A.·Registered Oct 03, 2018 – Oct 03, 2028ActiveRegistration details
- Analysis ID
- bef74d8335aa691c2ca40e84c0fea762
- License Form
- Ministry of Health Medical Device Import No. 019667
- Customs Code
- DHA09401966702
Company information
- Manufacturer
- BIOKIT S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the first level recognition range of the lipoprotein test system (A.1475) of the medical device management method.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1475 Lipoprotein Testing System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 03, 2018
- Expiry Date
- Oct 03, 2028
About this record
Access comprehensive regulatory information for “Abbott” Lp(a) Reagent Kit (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number bef74d8335aa691c2ca40e84c0fea762 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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