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In vitro diagnostic medical devices
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Reagents
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Microbiology (culture)
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Bacteriology - identification and susceptibility testing
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Biochemical identification and susceptibility testing - automated
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Gram negative susceptibility testing - automated
Gram negative susceptibility testing - automated
W0104080107
97 devices
Vitek® 2 Ast-N447
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N453
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N449
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-XN35
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N461
Biomérieux
·
,
United States
Class B
CE/IVDR
ASTar BC G- Kit software CE-IVDR
Q-Linea AB
·
,
Sweden
Class C
FDA 510(k)
K253573
Active
Cleared 15 Apr 2026
CE/IVDR
Vitek® 2 Ast-N402
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N404
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N424
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N468
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N386
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N470
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N451
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N403
Biomérieux
·
,
United States
Class B
CE/IVDR
Sensititre GN6F
Trek Diagnostic Systems Ltd
·
,
United Kingdom
Class B
CE/IVDR
Vitek® 2 Ast-N421
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-N395
Biomérieux
·
,
United States
Class B
CE/IVDR
Vitek® 2 Ast-XN36
Biomérieux
·
,
United States
Class B
CE/IVDR
Non-fermenting bacteria AST
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Vitek® 2 Ast-XN39
Biomérieux
·
,
United States
Class B
CE/IVDR
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