Vietnam MOH registration 2400514ĐKLH/BYT-HTTB

Parvovirus B19 DNA Detection and Quantification Kit

VN: Bộ xét nghiệm phát hiện và định lượng ADN của Parvovirus B19

Vietnam·Risk Class TTBYT Loại C·artus® Parvo B19 RG PCR Kit·QIAGEN GmbH·Registered Apr 10, 2024

Registration details

Analysis ID: 2400514ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-200924-0032
Product Type: artus® Parvo B19 RG PCR Kit
Product Code: 4504263

Company information

Manufacturer: QIAGEN GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: The Artus Parvo B19 RG PCR Kit is an in vitro nucleic acid amplification test for the detection and quantification of parvovirus B19 DNA in human serum or EDTA blood. The kit uses real-time polymerase chain reaction (PCR) and is designed to be used with the QIAamp UltraSens Virus Kit, QIAamp DNA Mini Kit and the Rotor-Gene Q device. This test kit is not intended for use as a blood screening test to detect parvovirus B19 infection. The Artus Parvo B19 RG PCR kit is intended for in vitro diagnostic use by medical professionals.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for Parvovirus B19 DNA Detection and Quantification Kit 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 2400514ĐKLH/BYT-HTTB and manufactured by QIAGEN GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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