Vietnam MOH registration 2301694ĐKLH/BYT-HTTB

Qualitative DNA test for human herpes simplex virus 1 (HSV-1) and human herpes simplex virus 2 (HSV-2)

VN: Bộ xét nghiệm định tính DNA của human herpes simplex virus 1 (HSV-1) và human herpes simplex virus 2 (HSV-2)

Vietnam·Risk Class TTBYT Loại C·artus® HSV-1/2 QS-RGQ Kit·QIAGEN GmbH·Registered Dec 22, 2023

Registration details

Analysis ID: 2301694ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-200924-0029
Product Type: artus® HSV-1/2 QS-RGQ Kit
Product Code: 4500363

Company information

Manufacturer: QIAGEN GmbH
Manufacturer Country: GERMANY

Technical details

Intended Use: The Artus HSV-1/2 QS-RGQ Kit is an in vitro nucleic acid amplification test for the qualitative detection of DNA of human herpes simplex virus 1 and 2 (HSV 1 and 2) in cerebrospinal fluid (CSF) and blood plasma. This diagnostic test uses the polymerase chain reaction (PCR) and is designed to be used with the QIAsymphony SP/AS and Rotor Gene Q. The Artus HSV-1/2 QS-RGQ Kit, combined with clinical manifestations and other preclinical signs, is used to predict the disease.

Dates and status

Registration Date: Dec 22, 2023

About this record

Access comprehensive regulatory information for Qualitative DNA test for human herpes simplex virus 1 (HSV-1) and human herpes simplex virus 2 (HSV-2) 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 2301694ĐKLH/BYT-HTTB and manufactured by QIAGEN GmbH.

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