15 results · 50ms · Sources: EU EUDAMED, US FDA

BioFire Respiratory Panel 2.1

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

BioFire Respiratory Panel 2.1 (RP2.1)

FDA 510(k)
FDA Class 2 ·Microbiology

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification
FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Cell-Free DNA BCT

FDA registration
STRECK LLC·1 product·🇺🇸 United States

Cell-Free DNA BCT

FDA registration
STRECK LLC·1 product·🇺🇸 United States

FEops HEARTguide

FDA registration
FEOPS NV·1 product·🇧🇪 Belgium

Invitae Non-Invasive Prenatal Screen (NIPS) Collection Kit

FDA registration
ALOM TECHNOLOGIES CORPORATION·1 product·🇺🇸 United States

Cell-Free DNA BCT

FDA registration
Precision Medical Devices Inc·1 product·🇺🇸 United States

Veteran Healing Traver

FDA registration
FUTUREGEN LIFE CO LTD·1 product·🇰🇷 South Korea

NightWare

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

NIGHTWARE

FDA registration
NIGHTWARE·1 product·🇺🇸 United States

Cell-Free DNA BCT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Masimo SafetyNet

FDA 510(k)
FDA Class 2 ·Anesthesiology

Monitor For Opioid Induced Impairment Of Oxygenation

FDA classification
FDA Class 2 ·Monitor For Opioid Induced Impairment Of Oxygenation

Blood Collection Device For Cell-Free Nucleic Acid

FDA classification
FDA Class 2 ·Blood Collection Device For Cell-Free Nucleic Acid