Human Monkeypox Virus (MPV) IgG/IgM Antibody Rapid Test Device(Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

IQX GmbH

Authorized representative

🇦🇹 Austria·1 Manufacturer·12 Devices

IQC GmbH

Authorized representative

🇩🇪 Germany

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS

HEp-2000® IgG Fluorescent w/cs ANA-Ro Test System

FDA UDI

IMMUNO CONCEPTS INC·M7492280BRO1·HEp-2000® IgG FA w/cs ANA-Ro Test System - 280 ...

Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit

FDA UDI

Gold Standard Diagnostics Corporation·B350GSD0110220·Gold Standard Diagnostics Borrelia burgdorferi ...

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit

FDA UDI

Gold Standard Diagnostics Corporation·B350GSD0110180·Gold Standard Diagnostics Borrelia burgodorferi...

REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well)

FDA UDI

CORGENIX MEDICAL CORPORATION·00855360006045·INTENDED USE For the detection and semi-quanti...

Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green)

FDA UDI

ALBA BIOSCIENCE LIMITED·05060242471636·Anti-Human Globulin, Anti-IgG,-C3d; Polyspecifi...

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit

FDA UDI

Gold Standard Diagnostics Corporation·B350GSD1010220·Gold Standard Diagnostics Borrelia burgodorferi...

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit

FDA UDI

Gold Standard Diagnostics Corporation·B350GSD0610180·Gold Standard Diagnostics Borrelia burgodorferi...

REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well)

FDA UDI

CORGENIX MEDICAL CORPORATION·00855360006090·INTENDED USE Detection and semi-quantitation o...

QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp)

FDA UDI

INOVA DIAGNOSTICS, INC.·08426950594024·1. 10x Gliadin IgG II ELISA Plate 2. 5x 1.2mL G...

Labmaster LUCIA™ SARS-CoV-2 IgG NP Kit For Serum/Plasma Samples

Device

EU IVDD · Eu Ivd General ·Labmaster Oy·On the market

Labmaster LUCIA™ SARS-CoV-2 IgG RBD Kit for Whole Blood Samples

Device

EU IVDD · Eu Ivd General ·Labmaster Oy·On the market

Labmaster LUCIA™ SARS-CoV-2 IgG NP Kit for Whole Blood Samples

Device

EU IVDD · Eu Ivd General ·Labmaster Oy·On the market

IGG

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Medicon Hellas SA·4 devices

IgG

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk

FDA UDI

Gold Standard Diagnostics Corporation·B350GSD0410220·Gold Standard Diagnostics Borrelia burgdorferi ...

Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit

FDA UDI

Gold Standard Diagnostics Corporation·B3507204400·Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) ...