273 results · 46ms · Sources: EU EUDAMED, US FDA

Fungitell (cleared as Glucatell)

FDA registration
ASSOCIATES OF CAPE COD, INC.·1 product·🇺🇸 United States

Fungitell STAT

FDA registration
ASSOCIATES OF CAPE COD, INC.·1 product·🇺🇸 United States

Fungitell STAT

FDA 510(k)
FDA Class 2 ·Microbiology

GLUCATELL

FDA 510(k)
FDA Class 2 ·Microbiology

Antigen, Invasive Fungal Pathogens

FDA classification
FDA Class 2 ·Antigen, Invasive Fungal Pathogens

DEMEDITEC DIAGNOSTICS GmbH

FDA registration
DEMEDITEC DIAGNOSTICS GmbH·1 product·🇩🇪 Germany

AlcoMate Premium

FDA registration
SENTECH KOREA CORP.·1 product·🇰🇷 South Korea

TEST AND DRIVE

FDA registration
TEST AND DRIVE·1 product·🇵🇱 Poland

Breath Alcohol Test

FDA registration
ASSURE TECH. (HANGZHOU) CO., LTD.·1 product·🇨🇳 China

AlcoHAWK

FDA registration
Quest Products, Inc·1 product·🇺🇸 United States

QuickVue Adenoviral conjunctivitis Test

FDA registration
QUIDEL CORP.·1 product·🇺🇸 United States

TruCheck

FDA registration
AMERICAN SCREENING CORPORATION·1 product·🇺🇸 United States

GOA / ANTISERA, CF, ADENOVIRUS 1-33

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

KT-842 Fecal Adenovirus Antigen ELISA Kit

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

KHN SOLUTIONS LLC

FDA registration
KHN SOLUTIONS LLC·1 product·🇺🇸 United States

Rapid Response Alcohol Breath Detector

FDA registration
BTNX Inc.·1 product·🇨🇦 Canada

PAS Alcovisor Mark V Breath Alcohol Analyzer

FDA registration
PAS SYSTEMS INTERNATIONAL INC·1 product·🇺🇸 United States

AlcoQuant 6020 Plus

FDA registration
Honeywell Healthcare Solutions GmbH (formerly EnviteC)·1 product·🇩🇪 Germany

RPS Adeno Detector, Catalogs: RPS-AD, RPS-DE, FSC-AD, NIC-AD

FDA registration
Integra Biotechnical, SA de CV·1 product·🇲🇽 Mexico

Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China