5,688 results
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53ms
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Sources: EU EUDAMED, US FDA
HemosIL AcuStar Anti-Cardiolipin IgG Controls
FDA UDI
INSTRUMENTATION LABORATORY COMPANY·08426950496991·HemosIL AcuStar Anti-Cardiolipin IgG Controls
Anti-Human IgG/A/M Conjugate
FDA UDI
IMMUCOR GTI DIAGNOSTICS, INC.·10888234500582·For Use with Pak12 and PakPlus
Anti-Gliadin (GAF-3X) ELISA (IgG)
FDA UDI
EUROIMMUN Medizinische Labordiagnostika AG·04049016035954·
IgG Anti-nDNA Fluorescent Test System
FDA UDI
IMMUNO CONCEPTS INC·M74903005G1·IgG anti-nDNA Fluorescent Bulk Pack - 700 Tests
Surgical 3D Video Microscope KestrelView II
FDA UDI
MITAKA KOHKI CO., LTD.·04589698450206·The KV2 is for use as surgical microscope desig...
Surgical Microscope MM51/YOH
FDA UDI
MITAKA KOHKI CO., LTD.·04589698450176·The MM51/YOH is for use as surgical microscope ...
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
ACCURUN 130 Borrelia burgdorferi IgG Positive Control
Device
EU IVDD
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Eu Ivd General
·LGC Clinical Diagnostics, Inc.·On the market
Rapid HAV IgG/IgM Combo Test Card
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
Rapid Rickettsia IgG/IgM Combo Test Card
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
Evo Autoimmune Control, b2-GPI IgG/IgM
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Control, AGA/tTG IgA/IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Control, MPO/PR3/GBM IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Control, DNA/HIS/NUC IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Evo Autoimmune Standard, anti-b2-GPI IgG
Device
EU IVDR
·
Eu Ivd Class A
·ABD SRL·On the market·2 countries
Sharay Anti-SS-B/La IgG (CLIA)
Device
EU IVDD
·
Eu Ivd General
·C-Luminary Biotechnology Co., Ltd.·No longer on the market
ACCURUN 25 ToRCH IgG Positive Control S2000
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·On the market
ACCURUN 25 ToRCH IgG Positive Control S5000
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·On the market
Rapid Dengue IgG/IgM Combo Test Card
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
Herpes Simplex Virus 1+2 IgG(CLIA)
Device
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries