Pentavalent Antiserum to Human Immu

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States

IgE AccuBind® ELISA Test System (Ref 2525-300A and 2525-300B)

FDA registration

MONOBIND, INC.·1 product·🇺🇸 United States

Trivalent Antiserum

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER

FDA registration

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER·1 product·🇯🇵 Japan

IEP Normal Human Serum Control

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States

Evo Autoimmune Control, AGA/tTG IgA/IgG

Device

EU IVDR · Eu Ivd Class A ·ABD SRL·On the market·2 countries

Oxygen Demand Valve , 2M Hose - AGA Probe

Device

EU MDR · Eu Md Class 2a ·BNOS MediTECH·On the market·1 country

Demand Valve, 3M Hose - AGA (NORDIC) Probe

Device

EU MDR · Eu Md Class 2a ·BNOS MediTECH·On the market·2 countries

DIGIFLOW 15l/min W/CONNECTOR AGA-O2

Device

EU MDD · Eu Md Class 2b ·S.E. Carburos Metálicos, S.A.·On the market·1 country

IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

AMPLATZER VASCULAR PLUG 4

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER VASCULAR PLUG

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER RELIANT CATHETER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER TORQVUE EXCHANGE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER SIZING BALLOON II

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER TORQVUE FX

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER NOODLEWIRE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular