Vietnam MOH registration 240000060/PCBB-HCM

The Semi-quantitative Self-antibody Test Kit for 25 types of Autoantigens

VN: Bộ xét nghiệm bán định lượng tự kháng thể của 25 loại kháng nguyên tự miễn

Vietnam·Risk Class TTBYT Loại B·ANA25Q-24·D.TEK·Registered Jan 04, 2024

Registration details

Analysis ID: 240000060/PCBB-HCM
Submission ID: 000.00.19.H29-231218-0013
Product Type: ANA25Q-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 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

Registration Date: Jan 04, 2024

About this record

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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