10,000 results · 45ms · Sources: EU EUDAMED, US FDA

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP

FDA 510(k)
FDA Class 1 ·Microbiology

STREP B OIA

FDA 510(k)
FDA Class 1 ·Microbiology

BD Veritor™ Plus CLIA-Waived Combo Pack

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902560746·Combo Veritor Plus CLIA- Waived Flu Kit

BD Veritor™ System Laboratory Combo Pack

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902560739·BD Veritor™ System Laboratory Combo Pack Contai...

BD Veritor™ Plus Laboratory Combo Pack

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902560708·Combo Veritor Reader 2 Hospital Flu Kit

Nuclease-Free Water

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

Streptavidin-PE

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

LIFECODES Taq Polymerase

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

Concentrated Wash

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

PF4 Concentrated Wash

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

Specimen Diluent

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

Dilution Solution

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

LIFECODES Wash Buffer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Immucor GTI Diagnostics, Inc·1 device

IMMUCOR Medizinische Diagnostik GmbH

Authorized representative
🇩🇪 Germany·4 Manufacturers·36 Devices

HX 1804149-1

Certificate
IVDR QMS·Immucor GTI Diagnostics, Inc·TÜV Rheinland LGA Products GmbH

Gorenje GTI, trgovina, inženiring, d.o.o.

Importer
🇸🇮 Slovenia

Antisera, Fluorescent, All Groups, N. Meningitidis

FDA classification
FDA Class 2 ·Antisera, Fluorescent, All Groups, N. Meningitidis

Antigens, All Groups, Streptococcus Spp.

FDA classification
FDA Class 1 ·Antigens, All Groups, Streptococcus Spp.

GENNY FACTORY SA

Manufacturer
🇨🇭 Switzerland·1 Basic UDI-DI·1 Device

LGI PLUS

FDA registration
HI TEC IMPLANTS, LTD.·2 products·🇮🇱 Israel