BD MAX Chlamydomydia/Gonococcus/Trichomonas vaginaliensis test set is second generation - Taiwan Registration 9a5bf484e16b5374fad9eee0934fe75c
Access comprehensive regulatory information for BD MAX Chlamydomydia/Gonococcus/Trichomonas vaginaliensis test set is second generation in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9a5bf484e16b5374fad9eee0934fe75c and manufactured by Benex Limited;; GeneOhm Sciences Canada, ULC.. The authorized representative in Taiwan is BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE).
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Device Details
Registration Details
9a5bf484e16b5374fad9eee0934fe75c
DHA05603619401
Product Details
This product is used with the BD MAX system, combined with automated DNA extraction and real-time polymerase chain reaction (PCR), for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis, TV, and this test is suitable for the detection of patients' own ( Vaginal swabs, cervical swabs, male and female urine specimens, and their CT, GC, and/or TV DNA stored in the ThinPrep PreservCyt Solution were removed prior to processing the ThinPrep Pap smear test. This test is indicated in both asymptomatic and symptomatic individuals to help diagnose urogenital chlamydomydia, urogenital gonorrhoea and/or trichomoniasis. Because vaginal swabs have a higher clinical sensitivity for detecting Trichomonas vaginalis than other types of specimens, vaginal swabs are the recommended specimen for women to detect Trichomonas vaginalis. However, if a vaginal swab is not available, a cervical swab or urine sample may be used as an alternative.
C Immunology and microbiology
C.3860 ้ฐ้ๆปด่ฒๆ ธ้ ธๆชข้ฉ่ฉฆๅ;; C.3390 ๅฅ็ๆฐ่ๅฑฌ็ดๆฅ่กๆธ ่ฉฆๅ;; C.3120 ๆซ่กฃ่่กๆธ ่ฉฆๅ
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jun 27, 2023
Jun 27, 2028