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Sources: EU EUDAMED, US FDA
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The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·June 20, 2018
OKO SOLUTION
Importer
🇫🇷 France·11 Manufacturers
AST Visioncare France
Importer
🇫🇷 France·4 Manufacturers
BIO-TECHNE SAS
Importer
🇫🇷 France·5 Manufacturers
Shockwave Medical France
Importer
🇫🇷 France·2 Manufacturers
AVF Biomédical
Importer
🇫🇷 France·2 Manufacturers
L3 MEDICAL
Importer
🇫🇷 France·2 Manufacturers
DINNO SANTE
Importer
🇫🇷 France·5 Manufacturers
bioMérieux SA
Importer
🇫🇷 France·7 Manufacturers
OPHTA-France
Importer
🇫🇷 France·8 Manufacturers
CRISTALENS
Importer
🇫🇷 France·5 Manufacturers
IntraMed France SAS
Importer
🇫🇷 France·4 Manufacturers
ELITech Distribution S.A.S.
Importer
🇫🇷 France·1 Manufacturer
EYEVAN Europe
Importer
🇫🇷 France·1 Manufacturer
Gaze Intelligence
Importer
🇫🇷 France·1 Manufacturer
OPENIVF
Importer
🇫🇷 France·1 Manufacturer
LANDANGER
Importer
🇫🇷 France·1 Manufacturer
PURGO BIOLOGICS EUROPE SAS
Importer
🇫🇷 France·1 Manufacturer
Ziwig
Importer
🇫🇷 France·1 Manufacturer
GE Healthcare SAS
Importer
🇫🇷 France·1 Manufacturer