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510(k) Data Aggregation
K Number
K002139Device Name
ETEST LINEZOLID
Manufacturer
AB BIODISK
Date Cleared
2000-11-08
(114 days)
Product Code
LTX
Regulation Number
866.1620Why did this record match?
Product Code :
LTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992993Device Name
ETEST FOR QUINUPRISTIN/DALFOPRISTIN
Manufacturer
AB BIODISK
Date Cleared
1999-11-16
(70 days)
Product Code
LTX
Regulation Number
866.1620Why did this record match?
Product Code :
LTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For In vitro diagnostic use:
Etest is a quantitative technique for the determination of antimirrohial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in uy/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This Etest 510(k) application is for MIC determination of Quinupristin/Dalfopristin in the range of 0.002 - 32 µg/ml with multi-resistant, including Vancomycin resistant, Enteroccoccus faecium and Methicillin-susceptible Staphylococcus aureus.
Device Description
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