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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Autoimmune connective tissue diseases
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Ds DNA - antibodies
Ds DNA - antibodies
W0102100105
57 devices
BioCLIA Autoimmune Reagent Kit, dsDNA
HOB Biotech Group Corp., Ltd.
·
,
China
IVD General
CE/IVDD
Anti-dsDNA CLIA Assay Kit
DiYaLab ZJG Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
Anti-dsDNA Antibody Chemiluminescent Immunoassay Kit
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
EliA dsDNA Well
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Anti dsDNA IgG
Dia.Metra Srl
·
,
Italy
IVD General
CE/IVDD
Sharay Anti-dsDNA IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Aptiva
Inova Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDR
FDA 510(k)
K213403
Active
Cleared 29 Sep 2023
+2
authorizations
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