Vietnam MOH registration 2403716ĐKLH/BYT-HTTB

Qualitative Neisseria gonorrhoeae Test Kit

VN: Bộ xét nghiệm định tính Neisseria gonorrhoeae

Vietnam·Risk Class TBYT Loại C·GeneProof Neisseria gonorrhoeae PCR Kit·GeneProof a.s.·Registered Nov 19, 2024

Registration details

Analysis ID: 2403716ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220617-0001
Product Type: GeneProof Neisseria gonorrhoeae PCR Kit
Product Code: NG/ISEX/025, NG/ISEX/100

Company information

Manufacturer: GeneProof a.s.
Manufacturer Country: CZECH REPUBLIC
Product Owner: GeneProof a.s
Authorized Representative: CÔNG TY CỔ PHẦN VẬT TƯ KHOA HỌC BIOMEDIC

Technical details

Intended Use: The GeneProof Neisseria gonorrhoeae PCR Kit uses the principle of real-time PCR to qualitatively detect N. gonorrhoeae based on the amplification of the 16S rRNA gene sequence and the porA pseudogene, which is specific to N. gonorrhoeae, and measures the increase in fluorescence signal. The presence of N. gonorrhoeae is determined by the increase in the FAM fluorescence channel signal. The kit includes an internal control (IS – Internal Standard), which is detected in the HEX fluorescence channel, and is used as a control for both PCR inhibition and the efficiency of nucleic acid purification. The GeneProof Neisseria gonorrhoeae PCR Kit is a certified diagnostic tool for clinical diagnostic equipment, as per the In Vitro Diagnostic Medical Devices Directive 98/97/EC of the European Union, and is designed for specialized use in research and clinical laboratories.

Dates and status

Registration Date: Nov 19, 2024

About this record

Access comprehensive regulatory information for Qualitative Neisseria gonorrhoeae Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403716ĐKLH/BYT-HTTB and manufactured by GeneProof a.s.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN VẬT TƯ KHOA HỌC BIOMEDIC.

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