9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
FDA Enforcement
Class III
·Terminated·Biomerieux Inc·April 15, 2015
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
FDA Enforcement
Class III
·Terminated·Biomerieux Inc·April 15, 2015
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
FDA Enforcement
Class III
·Terminated·Biomerieux Inc·April 15, 2015
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.
FDA Enforcement
Class III
·Terminated·Biomerieux France Chemin De L'Or·September 21, 2016