19 results · 41ms · Sources: EU EUDAMED, US FDA

Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit

FDA registration
GOLD STANDARD DIAGNOSTICS, LLC·1 product·🇺🇸 United States

IS-ANTI-MPO IGG ELISA TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA classification
FDA Class 2 ·Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

CADD Administration Set

FDA registration
ICU Medical, Inc.·1 product·🇺🇸 United States

Mark V ProVis Angiographic Injection System

FDA registration
Bayer Medical Care Inc.·1 product·🇺🇸 United States

Medrad Mark V-Plus Injector

FDA registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·1 product·🇳🇱 Netherlands

Bayer1673 (SX) -ProVis 150 mL FasTurn Sterile Disposable Syringe (150-FT)

FDA registration
Synergy Health AST, LLC·1 product·🇺🇸 United States

CADD Administration Set

FDA registration
ICU Medical Healthcare Manufacturing S.A. de C.V.·1 product·🇲🇽 Mexico

Isomedix Operations Inc.

FDA registration
Isomedix Operations Inc.·1 product·🇺🇸 United States

Medrad Pro Vis

FDA registration
CANUTE INTERNATIONAL MEDICAL SERVICES (CANADA) INC·1 product·🇨🇦 Canada

SEKISUI DIAGNOSTICS, LLC

FDA registration
SEKISUI DIAGNOSTICS, LLC·1 product·🇺🇸 United States

Sekisui Diagnostics, LLC

FDA registration
Sekisui Diagnostics, LLC·1 product·🇺🇸 United States

VITROS CA 15-3 Calibrator

FDA registration
Ortho-Clinical Diagnostics European Support Center·1 product·🇫🇷 France

Sekisui Diagnostics, LLC

FDA registration
Sekisui Diagnostics, LLC·1 product·🇺🇸 United States

VITROS CA 15-3 Calibrator

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

PMD SYSTEM-20

FDA 510(k)
FDA Class 1 ·General Hospital

QNext and DG-PT

FDA 510(k)
FDA Class 2 ·Hematology

Monitor, Bed Patient

FDA classification
FDA Class 1 ·Monitor, Bed Patient

System, Multipurpose For In Vitro Coagulation Studies

FDA classification
FDA Class 2 ·System, Multipurpose For In Vitro Coagulation Studies