Vietnam MOH registration 2403401ĐKLH/BYT-HTTB

Qualitative Troponin I Test

VN: Khay thử xét nghiệm định tính Troponin I

Vietnam·Risk Class TBYT Loại C·OnSite Troponin I Combo Rapid Test·Beijing Genesee Biotech, Inc.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403401ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230523-0007
Product Type: OnSite Troponin I Combo Rapid Test
Product Code: R3002C

Company information

Manufacturer: Beijing Genesee Biotech, Inc.
Manufacturer Country: CHINA
Product Owner: CTK Biotech, Inc.
Authorized Representative: CÔNG TY TNHH AVANTA DIAGNOSTICS

Technical details

Intended Use: The OnSite Troponin I Combo Rapid Test is an immunoassay device, based on the principle of unidirectional flow, for qualitative detection of cardiac Troponin I (cTnI) and its complex in serum, plasma, or whole blood of humans at levels equal to or greater than 1 ng/mL. It is intended to be used as a screening test by a qualified individual, to support the diagnosis of acute myocardial infarction (AMI).

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Qualitative Troponin I Test 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 2403401ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.

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