BD MAX Chlamydomydia/Gonococcus/Trichomonas vaginaliensis test set is second generation
Taiwan·Risk Class 2·Benex Limited;; GeneOhm Sciences Canada, ULC.·Registered Jun 27, 2023 – Jun 27, 2028Active- Analysis ID
- 9a5bf484e16b5374fad9eee0934fe75c
- Customs Code
- DHA05603619401
- Manufacturer
- Benex Limited;; GeneOhm Sciences Canada, ULC.
- Manufacturer Country
- Canada;;Ireland
- Authorized Representative
- BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE)
- Intended Use
- 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.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3860 陰道滴蟲核酸檢驗試劑;; C.3390 奈瑟氏菌屬直接血清試劑;; C.3120 披衣菌血清試劑
- Import Information
- QMS/QSD;; 輸入
- Registration Date
- Jun 27, 2023
- Expiry Date
- Jun 27, 2028
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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