"Abete" BK Virus Test Set Amplification Reagent Set (Non-sterile) - Taiwan Registration 4ee0954e536ff70f824f5f92b80db22d
Access comprehensive regulatory information for "Abete" BK Virus Test Set Amplification Reagent Set (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 4ee0954e536ff70f824f5f92b80db22d 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
This product is an in vitro nucleic acid amplification test for the quantification of BK virus (BKV) DNA in human EDTA plasma and urine stabilized in delivery buffer on an automated Alinity m system. This product is used to assist in the management of BKV in transplant patients in the stable EDTA plasma and urine in the delivery buffer. When a patient is monitored for BKV with EDTA plasma, serial DNA measurements can be used to indicate the need for a change in treatment and to assess the viral response to treatment. Results of this product must be interpreted in conjunction with clinical symptoms and other relevant laboratory findings. Test results should not be used as the sole basis for patient management decisions. This product is not intended for use as a screening test for blood or blood products or human cells, tissues and cell- and tissue-based products.
C Immunology and microbiology
C.9999 Miscellaneous
Input;; QMS/QSD
Dates and Status
Aug 07, 2024
Aug 07, 2029