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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
EKOI INC
FDA registration
EKOI INC·1 product·🇫🇷 France
ODC INDUSTRIES
FDA registration
ODC INDUSTRIES·1 product·🇫🇷 France
OKO SOLUTION
Importer
🇫🇷 France·11 Manufacturers
MedPass SAS
Authorized representative
🇫🇷 France·13 Manufacturers·130 Devices
MediMark Europe Sarl.
Authorized representative
🇫🇷 France·35 Manufacturers·3394 Devices
Bio-Rad
Authorized representative
🇫🇷 France·6 Manufacturers
Ortho-Clinical Diagnostics France
Authorized representative
🇫🇷 France·5 Manufacturers
Tornier SAS
Authorized representative
🇫🇷 France·2 Manufacturers
BIO-TECHNE SAS
Authorized representative
🇫🇷 France·2 Manufacturers
OKO SOLUTION
Authorized representative
🇫🇷 France·2 Manufacturers·44 Devices
Sofibel
Authorized representative
🇫🇷 France·5 Manufacturers·81 Devices
SMB EUROPE SAS
Authorized representative
🇫🇷 France·23 Manufacturers·42 Devices
Hill-Rom S.A.S.
Authorized representative
🇫🇷 France·3 Manufacturers
S4M EUROPE
Authorized representative
🇫🇷 France·13 Manufacturers·120 Devices
Blue Ortho SAS
Authorized representative
🇫🇷 France·1 Manufacturer
MICROVENTION EUROPE
Authorized representative
🇫🇷 France·1 Manufacturer
EYEVAN Europe
Authorized representative
🇫🇷 France·1 Manufacturer·1910 Devices
DIAGNOTIS SAS
Authorized representative
🇫🇷 France·1 Manufacturer·1 Device
BENOIT HALLIER Consulting & Solutions
Authorized representative
🇫🇷 France·1 Manufacturer