Abbott BK Virology Test Quality Control Group Calibration Group - Taiwan Registration 00dfb6082ae4af53b41e66b32c618dfb
Access comprehensive regulatory information for Abbott BK Virology Test Quality Control Group Calibration Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 00dfb6082ae4af53b41e66b32c618dfb and manufactured by ABBOTT MOLECULAR INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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Device Details
Product Details
Alinity m BKV CTRL Kit This product is used to measure the effectiveness of the Quantitative Abbot BK Virometry Panel Amplification Kit on an automated Alinity m system. These quality control solutions should be used in conjunction with the Abbotel BK Viral Load Test Kit and Amplification Reagent Set; For more information, refer to the Abbotel BK Virometry Panel Amplification Kit Instructions. The Alinity m BKV CAL Kit is designed to calibrate the Abbotet BK Virometry Panel Amplification Reagent Set for the quantitative detection of BKV DNA on the automated Alinity m System. The calibration solution should be used with the ABK virometry test kit and amplification reagent set; For more information, refer to the Abbotel BK Virometry Panel Amplification Kit Instructions.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Input;; QMS/QSD
Dates and Status
Oct 21, 2024
Oct 21, 2029