Vietnam MOH registration 2301800ĐKLH/BYT-HTTB

Qualitative DNA Test Kit for Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, and Trichomonas vaginalis

VN: Bộ xét nghiệm định tính ADN Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum và Trichomonas vaginalis

Vietnam·Risk Class TTBYT Loại C·Allplex™ STI Essential Assay·Seegene, Inc.·Registered Dec 30, 2023

Registration details

Analysis ID: 2301800ĐKLH/BYT-HTTB
Submission ID: 19010830/ĐKLH-BYT-TB-CT
Product Type: Allplex™ STI Essential Assay
Product Code: SD9801X

Company information

Manufacturer: Seegene, Inc.
Manufacturer Country: REPUBLIC OF

Technical details

Intended Use: Qualitative in vitro testing to detect single or multiple pathogens C. trachomatis (CT), N. gonorrhoeae (NG), M. genitalium (MG), M. hominis (MH), U. urealyticum (UU), U. parvum (UP) and T. vaginalis (TV) from urine samples, genital swabs, liquid cell cultures, semen, and throat and rectal swabs.

Dates and status

Registration Date: Dec 30, 2023

About this record

Access comprehensive regulatory information for Qualitative DNA Test Kit for Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, and Trichomonas vaginalis 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 2301800ĐKLH/BYT-HTTB and manufactured by Seegene, Inc..

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