147 results · 42ms · Sources: EU EUDAMED, US FDA

XPERT EV

FDA registration
CEPHEID·1 product·🇺🇸 United States

OAI / assay, enterovirus nucleic acid

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

Xpert EV

FDA UDI
CEPHEID·07332940000097·Xpert EV kit; 10 test kit

NUCLISENS EASYQ ENTEROVIRUS SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)
FDA Class 2 ·Microbiology

Assay, Enterovirus Nucleic Acid

FDA classification
FDA Class 2 ·Assay, Enterovirus Nucleic Acid

Alinity

FDA UDI
Abbott Ireland Diagnostics·00380740153953·Alinity i BRAHMS PCT Reagent Kit 200 Tests

Atellica IM BRAHMS PCT

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414246550·Procalcitonin (PCT) Atellica IM - RGT 100T

BION ECHOVIRUS ANTI

FDA registration
BION ENTERPRISES, LTD.·1 product·🇺🇸 United States

RapidLight PCT CLIA Test (REF# L0400)

FDA registration
CTK BIOTECH, INC.·1 product·🇺🇸 United States

Elecsys BRAHMS PCT

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

GNJ / ANTIGENS, HA, ECHOVIRUS 1-34

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

MeMed BV TM

FDA registration
MICROCOAT BIOTECHNOLOGIE GMBH·1 product·🇩🇪 Germany

MeMed BV

FDA registration
MeMed Inc·1 product·🇺🇸 United States

Intellisep Cartridge

FDA registration
Westec Plastics Corporation·1 product·🇺🇸 United States

Diazyme Procalcitonin (PCT) Assay

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

VITROS BRAHMS PCT Range Verifier

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

AbioSCOPE, IVD CAPSULE PSP

FDA registration
ABIONIC SA·1 product·🇨🇭 Switzerland

Cytovale Diluent

FDA registration
Cytovale, Inc. (PBRC)·1 product·🇺🇸 United States

Atellica IM BRAHMS Procalcitonin (PCT)

FDA registration
Siemens Healthcare Diagnostics Inc.·1 product·🇺🇸 United States