Vietnam MOH registration 2403545ĐKLH/BYT-HTTB

Khay thử xét nghiệm định tính kháng thể IgM, IgG kháng lao

Trueline™ TB IgG/IgM Rapid Test

Vietnam·Risk Class TTBYT Loại C·TB IgG/IgM Rapid Test·Medicon Co., Ltd.·Registered Nov 14, 2024

Registration details

Analysis ID: 2403545ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240719-0006
Product Type: TB IgG/IgM Rapid Test
Product Code: ITBB-402

Company information

Manufacturer: Medicon Co., Ltd.
Manufacturer Country: VIET NAM
Product Owner: Công ty TNHH Medicon
Authorized Representative: CÔNG TY TNHH MEDICON

Technical details

Intended Use: In-vitro qualitative test for the detection of IgM and IgG antibodies against M. tuberculosis in the whole blood, serum, or plasma of humans.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Khay thử xét nghiệm định tính kháng thể IgM, IgG kháng lao 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 2403545ĐKLH/BYT-HTTB and manufactured by Medicon Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH MEDICON.

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