Taiwan FDA registration 4a226fe39d48597a89830167d2d8d120

Abbott Alinity c Ferritin/Myoglobin/IgE Control Kit

TW: 亞培肌紅蛋白品管液組

Taiwan·Risk Class 2·MD·BIOKIT S.A.·Registered Oct 15, 2019 – Oct 15, 2024Expired

Registration details

Analysis ID: 4a226fe39d48597a89830167d2d8d120
License Form: Ministry of Health Medical Device Import No. 032943
Customs Code: DHA05603294309

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 results of the Apex Myoglobin Test set obtained by turbidimetry. This product should be used with the Api Myoglobin Test Set on the Alinity c Analyzer.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1660 Quality Control Materials (Analytical and Non-Analytical)
Import Information: Imported from abroad

Dates and status

Registration Date: Oct 15, 2019
Expiry Date: Oct 15, 2024

About this record

Access comprehensive regulatory information for Abbott Alinity c Ferritin/Myoglobin/IgE Control Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4a226fe39d48597a89830167d2d8d120 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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