31 results · 20ms · Sources: EU EUDAMED, US FDA

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EBV VCA-P18 IGG ELISA

FDA 510(k)
FDA Class 1 ·Microbiology

EBV-EBNA IGG ELISA KIT, MODEL EBG-100

FDA 510(k)
FDA Class 1 ·Microbiology

EBV-VCA IGG ELISA TEST, MODEL EBG-100

FDA 510(k)
FDA Class 1 ·Microbiology

EBV EA-D IGG ELISA KIT, MODEL EBG-100

FDA 510(k)
FDA Class 1 ·Microbiology

EBV V VCA IGM ELISA KIT MODEL# EBM-200

FDA 510(k)
FDA Class 1 ·Microbiology

Eyetelligence Pty Ltd, an Optain Health Company

Manufacturer
🇦🇺 Australia

ICU Medical Australia Pty Limited

Manufacturer
🇦🇺 Australia

Atomo Diagnostics Limited

Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

CareDx Pty Ltd

Manufacturer
🇦🇺 Australia

Novapharm Research (Australia) Pty Ltd

Manufacturer
🇦🇺 Australia

Kico Knee Innovation Company Pty Ltd

Manufacturer
🇦🇺 Australia

DoseMe

Manufacturer
🇦🇺 Australia

Anteris Aus Operations Pty Ltd

Manufacturer
🇦🇺 Australia

Uscom Limited

Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

SpeeDx Pty. Ltd.

Manufacturer
🇦🇺 Australia·1 Basic UDI-DI·3 Devices·1 Importer

Simplitude ByMe

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

Simplitude ByMe

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

USCOM

Device
EU MDD · Eu Md Class 2a ·Uscom Limited·On the market·16 countries

BP+

Device
EU MDD · Eu Md Class 2a ·Uscom Limited·On the market·9 countries

PlexPCR RespiVirus (610)

Device
EU IVDR · Eu Ivd Class B ·SpeeDx Pty. Ltd.·On the market·1 country