5,688 results · 53ms · 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 · 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