BUSSE HOSPITAL DISPOSABLES

FDA registration

BUSSE HOSPITAL DISPOSABLES·1 product·🇺🇸 United States

QUANTA Flash® GBM Controls

FDA UDI

INOVA DIAGNOSTICS, INC.·08426950594888·1. QUANTA Flash GBM Negative Control: Two (2) b...

WIESLAB anti-GBM semi quantitative kit

FDA UDI

Euro-Diagnostica AB·07340058410721·

GBM IgG Test System

FDA UDI

SCIMEDX CORPORATION·00813545029029·

QUANTA Flash® GBM Calibrators

FDA UDI

INOVA DIAGNOSTICS, INC.·08426950595120·1. QUANTA Flash GBM Calibrator 1: Two (2) barco...

QUANTA LITE GBM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

GALIX GBI -3S-LP

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

NON-PRESCRIPTION SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse DR, Ellipse VR

EliA MPOs Immunoassay

FDA registration

PHADIA AB·2 products·🇸🇪 Sweden

EliA MPOs Immunoassay

FDA registration

PHADIA US INC.·2 products·🇺🇸 United States

FIDIS VASCULITIS

FDA registration

THERADIAG·2 products·🇫🇷 France

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

Sharay Anti-GBM IgG (CLIA)

Device

EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

AutoLumo Anti-GBM IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-GBM IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-GBM IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries