Taiwan FDA registration dae45b85c48b4f84d8eabc70395cadd3

Abbott antistreptolysin O and rheumatoid factor quality control solution

TW: 亞培抗鏈球菌溶血素O及類風濕因子品管液組

Taiwan·Risk Class 2·BIOKIT S.A.·Registered May 12, 2020 – May 12, 2030Active

Registration details

Analysis ID: dae45b85c48b4f84d8eabc70395cadd3
Customs Code: DHA05603348102

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 "Apepto" antistreptolysin O test set (unsterilized) and the Apex rheumatoid factor test set obtained by the turbidimetric method. This product should be used with the "Apbot" Antistreptolysin O Test Set (Unsterilized) and the Apex Rheumatoid Factor Test Set 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: import

Dates and status

Registration Date: May 12, 2020
Expiry Date: May 12, 2030

About this record

Access comprehensive regulatory information for Abbott antistreptolysin O and rheumatoid factor 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 dae45b85c48b4f84d8eabc70395cadd3 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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