394 results · 43ms · Sources: EU EUDAMED, US FDA

Film Array Respiratory Panel EZ (RPEZ)

FDA registration
Rommelag CDMO GmbH·1 product·🇩🇪 Germany

BUHLMANN fCAL® turbo (fecal calprotectin turbidimetric assay), CALEX® Cap (stool preparation device)

FDA registration
BUHLMANN LABORATORIES AG·1 product·🇨🇭 Switzerland

Diazyme Calprotectin Assay

FDA registration
Diazyme Laboratories, Inc.·1 product·🇺🇸 United States

NxTAG® Respiratory Pathogen Panel

FDA registration
LUMINEX MOLECULAR DIAGNOSTICS, INC.·1 product·🇨🇦 Canada

280750, illumigene Pertussis

FDA registration
MERIDIAN BIOSCIENCE, INC.·1 product·🇺🇸 United States

Human METAPNEUMOVIRUS (HMPV) RAPID

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

Bordetella pertussis dna assay system

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

PhiCal Test

FDA registration
EUROSPITAL S.P.A.·1 product·🇮🇹 Italy

Solana Bordetella Complete Assay

FDA registration
Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Solana RSV+hMPV Assay, M306

FDA registration
Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

NxTAG Respiratory Pathogen Panel

FDA registration
Luminex Corporation·1 product·🇺🇸 United States

fCAL turbo URCI

FDA registration
Roche Diabetes Care GmbH·1 product·🇩🇪 Germany

CALPROTECTIN ELISA

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

Calprest

FDA registration
EUROSPITAL S.P.A.·1 product·🇮🇹 Italy

ALPCO Easy Stool Extraction Device

FDA registration
American Laboratory Products Company·1 product·🇺🇸 United States

RSV Rapid Test Cassette

FDA registration
ACRO BIOTECH Inc.·1 product·🇺🇸 United States

EasyCal

FDA registration
EUROSPITAL S.P.A.·1 product·🇮🇹 Italy

Fecal Extraction Device

FDA registration
EUROSPITAL S.P.A.·1 product·🇮🇹 Italy

LIAISON Q.S.E.T. Device Plus

FDA registration
DIASORIN INC.·1 product·🇺🇸 United States

OZX / Mycoplasma pneumoniae DNA assay system

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States