Vietnam MOH registration 240000059/PCBB-HCM

The Semi-quantitative Self-antibody Test Kit for 10 Types of Autoantigens

VN: Bộ xét nghiệm bán định lượng tự kháng thể của 10 loại kháng nguyên tự miễn

Vietnam·Risk Class TTBYT Loại B·LI10Q-24·D.TEK·Registered Jan 04, 2024

Registration details

Analysis ID: 240000059/PCBB-HCM
Submission ID: 000.00.19.H29-231218-0014
Product Type: LI10Q-24

Company information

Manufacturer: D.TEK
Product Owner: D.TEK
Authorized Representative: CÔNG TY CỔ PHẦN XUẤT NHẬP KHẨU Y TẾ THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: BlueDiver Liver10 IgG is an Immunodot test designed to detect in human serum antibodies against M2/nPDC, M2/OGDC-E2, M2/BCOADC-E2, M2/PDC-E2, gp210, sp100, LKM1, LC1, SLA and f-Actin. The confirmatory test for the results of samples tested by the fluorescent immunodetection method (immunofluorescence) - the screening and reference method in the detection of autoimmune diseases; the test is designed to support the diagnosis of some autoimmune diseases. The test is intended for the general population and is specifically used in clinical laboratories. The test is an automated test and is intended to be used only on the BlueDiver Model I or II (hereinafter referred to as BDI I or BDI II). To obtain the quantitative test results, a BlueScan scanner and Dr Dot software are required. The scanning system and software are not available on BDI I, but are integrated into BDI II.

Dates and status

Registration Date: Jan 04, 2024

About this record

Access comprehensive regulatory information for The Semi-quantitative Self-antibody Test Kit for 10 Types of Autoantigens in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000059/PCBB-HCM and manufactured by D.TEK. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN XUẤT NHẬP KHẨU Y TẾ THÀNH PHỐ HỒ CHÍ MINH.

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