The Semi-quantitative Self-antibody Test Kit for 25 types of Autoantigens - Vietnam Registration 240000060/PCBB-HCM
Access comprehensive regulatory information for The Semi-quantitative Self-antibody Test Kit for 25 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 240000060/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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Device Details
Technical Details
BlueDiver Quantrix ANA25 Screen IgG is an Immunodot test for the detection of autoantibodies IgG against the following antigens: Nucleosome, dsDNA, Histones, Sm, RNP (68kD /A/C), Sm/RNP, SSA / Ro 60kD, SSA/Ro 52kD, SSB, Scl-70, Ku, PM-Scl 100, Mi-2, Jo-1, PL-7, PL-12, SRP, Ribosome, CENP-A/B, PCNA, sp100, gp210, M2 recombinant, M2/ nPDC and f-Actin in human serum. It is a confirmatory test for the results of antibody samples that have been tested by the fluorescent immunology (immunofluorescence) method - the screening and reference test in the detection of autoimmune diseases; it is a test designed to support the diagnosis of some autoimmune diseases. It is a test for the general population and is specifically intended for use in clinical laboratory analysis. The test is an automated test and is intended for use only on the BlueDiver Model I or II (hereinafter referred to as BDI I or BDI II). To obtain 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
Jan 04, 2024

