Qualitative DNA Test for Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG)
Vietnam·Risk Class TTBYT Loại C·NeuMoDx™ CT/NG Test Strip·NeuMoDx Molecular, Inc.·Registered Oct 22, 2024- Analysis ID
- 2402895ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210817-0029
- Product Type
- NeuMoDx™ CT/NG Test Strip
- Product Code
- 200300
- Manufacturer
- NeuMoDx Molecular, Inc.
- Manufacturer Country
- UNITED STATES
- Product Owner
- NeuMoDx Molecular, Inc.
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ KHOA HỌC VÀ CÔNG NGHỆ QMEDIC
- Intended Use
- The NeuMoDx CT/NG Assay, as performed on the NeuMoDx™ 96 Molecular System and the NeuMoDx™ 288 Molecular System, is a qualitative in vitro amplification test for the direct detection and differentiation of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The test uses real-time polymerase chain reaction (PCR) to detect the DNA of Chlamydia trachomatis and Neisseria gonorrhoeae in vaginal swab specimens obtained by the clinical physician, self-obtained vaginal swab specimens (obtained in the clinical setting), and cervical swab specimens, all of which are obtained using polyester-tipped swabs coated with plastic in a common transport medium (Universal Transport Medium, UTM-RT®, Copan Diagnostics, CA, USA or BD™ Universal Viral Transport System, BD™ UVT, Becton, Dickinson and Company, MD, USA or equivalent), cervical swab specimens obtained in PreservCyt® Solution (Hologic, Inc, MA, USA) and urine specimens from male and female patients. The NeuMoDx™ CT/NG Assay is used to aid in the diagnosis of urogenital infections caused by Chlamydia and Gonococcus in symptomatic and asymptomatic individuals.
- Registration Date
- Oct 22, 2024
Access comprehensive regulatory information for Qualitative DNA Test for Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402895ĐKLH/BYT-HTTB and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC VÀ CÔNG NGHỆ QMEDIC.
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