Apex Infectious Disease Test Kit - Taiwan Registration 094b048f5e7deb771c17ae0bc8cf81eb
Access comprehensive regulatory information for Apex Infectious Disease Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 094b048f5e7deb771c17ae0bc8cf81eb 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 test method using reverse transcription polymerase chain reaction (RT-PCR) technology, combined with the automated Alinity m system, which can directly and qualitatively detect and distinguish RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) and the RNA of Mycoplasma genitalium (MG) to help diagnose genitourinary diseases caused by infection with these microorganisms. This product is intended for CT, NG and TV for the detection of specimens from symptomatic and asymptomatic individuals including: endocervical swab specimens, vaginal swab specimens collected by clinical professionals, self-collected vaginal swab specimens (in clinical settings), gynaecological specimens collected in ThinPrep PreservCyt preservation solution, female urine, and male urine. This product is intended for MG and can be used to detect endocervical swab specimens in symptomatic and asymptomatic individuals.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Aug 17, 2020
Aug 17, 2025