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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
Devices
Vitek® 2 Ast-N416
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N457
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N422
Biomérieux
·
,
US
Class B
CE/IVDR
MBT STAR-Carba IVD Kit
Bruker Daltonics GmbH & Co. KG
·
,
DE
Class C
CE/IVDR
MBT STAR-Cepha IVD Kit
Bruker Daltonics GmbH & Co. KG
·
,
DE
Class C
CE/IVDR
Vitek® 2 Ast-N471
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N458
Biomérieux
·
,
US
Class B
CE/IVDR
Ast-NF01
Autobio Diagnostics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Vitek® 2 Ast-N480
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N444
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N367
Biomérieux
·
,
US
Class B
CE/IVDR
QuickMIC GN
Gradientech AB
·
,
SE
Class B
CE/IVDR
Vitek® 2 Ast-N476
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N438
Biomérieux
·
,
US
Class B
CE/IVDR
ASTar BC G- Kit software, (EUCAST)
Q-Linea AB
·
,
SE
Class C
CE/IVDR
Vitek® 2 Ast-N467
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N439
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-N437
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-XN40
Biomérieux
·
,
US
Class B
CE/IVDR
Vitek® 2 Ast-XN38
Biomérieux
·
,
US
Class B
CE/IVDR
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