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Product Classification / EMDN Category

FDA Product Code: W0102100101

Directory of devices assigned to product classification code W0102100101.

emdn_classification ANA SCREENING Manufacturer:
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eudamed_udi AESKUSLIDES® ANA HEp-2 Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi AESKULISA® ANA-8S Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi Anti-Nuc Antibody CLIA Assay Kit Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi BlueDiver Quantrix Manufacturer: D-tek s.a.
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eudamed_udi AESKUBLOTS® ANA-17 comp Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi ANA (HEp-2) IIFT Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
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eudamed_udi iStar-ANA Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi iStar-ANA Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi AutoLumo analyzer Manufacturer: Autobio Diagnostics Co., Ltd.
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eudamed_udi iStar-ANA Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi AESKULISA® ANA-8Pro Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi AESKULISA® ANA HEp-2 Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi Sharay ANA Screen (CLIA) Manufacturer: C-Luminary Biotechnology Co., Ltd.
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eudamed_udi DANA-Pro Manufacturer: AIDA GmbH
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eudamed_udi Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies Manufacturer: HOB Biotech Group Corp., Ltd.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi EliA CTD Screen Manufacturer: Phadia AB
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eudamed_udi ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi BlueDiver Dot ANA Manufacturer: D-tek s.a.
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eudamed_udi NOVA Lite® ANA KSL Kit Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi iStar-ANA Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi NOVA Lite® DAPI ANA Kit Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi iFlash-ANA Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
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eudamed_udi BlueDiver Dot ANA Manufacturer: D-tek s.a.
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eudamed_udi Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies Manufacturer: HOB Biotech Group Corp., Ltd.
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eudamed_udi AESKULISA® DANA-Pro Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi ANA Screen FIA Kit Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
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eudamed_udi ANA (HEp-20-10) IIFT Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
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eudamed_udi CHORUS ANA-SCREEN Manufacturer: DIESSE Diagnostica Senese S.p.A
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi AutoLumo analyzer Manufacturer: Autobio Diagnostics Co., Ltd.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
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eudamed_udi ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi ANA (HEp-2) IIFT Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
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eudamed_udi ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi AESKUSLIDES® ANA HEp-2 Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi ANA Screening Antibody CLIA Assay Kit Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi QUANTA Flash® CTD Screen Plus Reagents Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi QUANTA Lite® ANA ELISA Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi ANA screen Manufacturer: NEOMEDICA DOO NIŠ
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eudamed_udi Autoimmunity SPA ANA Screen - Autoimmunità SPA ANA Screen Manufacturer: ABD SRL
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eudamed_udi AESKUSLIDES® ANA HEp-2 Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi ANA Assay Kit (Fluorescence Immunoassay) Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi BlueDiver Quantrix ANA Manufacturer: D-tek s.a.
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi Anti-Nuc Antibody CLIA Assay Kit Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi Anti-Nuc Antibody CLIA Assay Kit Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi ANA (HEp-2) IIFT Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
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eudamed_udi AUTOANTIBODIES DUO-HEp2/ML (DUO-HEp2/ML) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi ANA Assay Kit (Fluorescence Immunoassay) Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi BlueDiver Quantrix ANA Manufacturer: D-tek s.a.
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eudamed_udi ANA Profile 8 ELISA Manufacturer: IBL International GmbH
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eudamed_udi Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies Manufacturer: HOB Biotech Group Corp., Ltd.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDiver Quantrix Manufacturer: D-tek s.a.
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eudamed_udi NOVA Lite® HEp-2 ANA Kit Manufacturer: Inova Diagnostics. Inc.
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eudamed_udi BlueDiver Dot ANA Manufacturer: D-tek s.a.
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eudamed_udi BlueDot ANA8 IgG Manufacturer: D-tek s.a.
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eudamed_udi ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi AESKUSLIDES® ANA HEp-2 Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi AESKUSLIDES® ANA HEp-2 Manufacturer: Aesku.Diagnostics GmbH & Co. KG
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eudamed_udi BlueDot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDot ANA10 IgG Manufacturer: D-tek s.a.
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eudamed_udi Anti-Nuc Antibody CLIA Assay Kit Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi BioCLIA Autoimmune Control Set, CTD Screen Manufacturer: HOB Biotech Group Corp., Ltd.
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eudamed_udi CHORUS ANA-8 Manufacturer: DIESSE Diagnostica Senese S.p.A
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eudamed_udi EliA SymphonyS Manufacturer: Phadia AB
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eudamed_udi Sharay ANA Screen (CLIA) Manufacturer: C-Luminary Biotechnology Co., Ltd.
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eudamed_udi IDS dsDNA igG Manufacturer: Immunodiagnostic Systems Limited
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi iStar-ANA Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
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eudamed_udi BlueDiver Dot ANA Screening Manufacturer: D-tek s.a.
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eudamed_udi BlueDiver Quantrix Manufacturer: D-tek s.a.
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eudamed_udi MASTAZYME™ ANA Screen Manufacturer: Mast Diagnostica GmbH
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eudamed_udi BioCLIA Autoimmune Calibrator Set, CTD Screen Manufacturer: HOB Biotech Group Corp., Ltd.
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eudamed_udi ANA Screening Antibody CLIA Assay Kit Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi ANA Screening Antibody CLIA Assay Kit Manufacturer: DiYaLab ZJG Biotech Co., Ltd
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eudamed_udi ANA (HEp-20-10) IIFT Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
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eudamed_udi BlueDot Connectivitis 10 IgG Manufacturer: D-tek s.a.
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eudamed_udi AutoLumo analyzer Manufacturer: Autobio Diagnostics Co., Ltd.
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eudamed_udi ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) Manufacturer: BIOSYSTEMS S.A.
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eudamed_udi ANA (HEp-20-10) IIFT Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
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eudamed_udi ANA Screen Manufacturer: Dia.Metra Srl
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