Accula Strep A Test

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

AMPLIVUE GAS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ALERE I STREP A

FDA 510(k)

FDA Class 2 ·Microbiology

LYRA DIRECT STREP ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

iDNA PGx CNS

Basic UDI-DI

EU IVDD · Eu Ivd General · iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ·1 device

PGx SW Engine

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Abomics Oy·1 device

iDNA PGx CNS kit

Basic UDI-DI

EU IVDD · Eu Ivd General · iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ·1 device

Respiratory virus panel nucleic acid assay system

FDA registration

ENERCON TECHNOLOGIES·4 products·🇺🇸 United States

SPOTFIRE R/ST Panel Mini

FDA registration

BioFire Diagnostics, LLC·5 products·🇺🇸 United States

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

FDA classification

FDA Class 2 ·Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Quick-20m

FDA registration

CGX, LLC·2 products·🇺🇸 United States

BGX-VTM

FDA registration

BIOGENEX LABORATORIES INC.·1 product·🇺🇸 United States

COALITION AGX

FDA registration

GLOBUS MEDICAL, INC.·3 products·🇺🇸 United States

Neitz Contact Gauge CGX-3 LED, CGX-4 LED; Neitz Contact Gauge CGX-3, CGX-4

FDA registration

NEITZ INSTRUMENTS COMPANY, LTD.·1 product·🇯🇵 Japan

PXG Pharma GmbH

Manufacturer

🇩🇪 Germany

Conform 2

FDA registration

HOLLISTER INCORPORATED·1 product·🇺🇸 United States

Conform 2

FDA registration

HOLLISTER ULC·1 product·🇮🇪 Ireland