Vietnam MOH registration 2403542ĐKLH/BYT-HTTB

Interferon gamma quantitative test kit

VN: Thuốc thử xét nghiệm định lượng interferon gamma

Vietnam·Risk Class TTBYT Loại C·Elecsys Interferon Gamma·Roche Diagnostics GmbH·Registered Nov 14, 2024

Registration details

Analysis ID: 2403542ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231103-0034
Product Type: Elecsys Interferon Gamma
Product Code: 09437622190

Company information

Manufacturer: Roche Diagnostics GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: Elecsys Interferon Gamma is an immunoassay test designed to determine the concentration of interferon gamma in the test tube in human blood samples. The test aims to assist in identifying patients with elevated levels of interferon gamma, which indicate inflammation or an increased sensitivity of the immune system. The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") fluorescent chemiluminescence immunoassay is used in cobase immunoassay analyzers.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Interferon gamma quantitative test 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 2403542ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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