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510(k) Data Aggregation
K Number
K093604Device Name
ETEST MOXIFLOXACIN 0.002-32 UG/ML
Manufacturer
Date Cleared
2010-08-25
(278 days)
Product Code
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
AB BIOMERIEUX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp.
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobaterianas, Staphylocourus and Entervacus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, Streptowers and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
Device Description
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K Number
K082534Device Name
ETEST VORICONAZOLE 0.002-32 UG/ML
Manufacturer
Date Cleared
2009-11-02
(426 days)
Product Code
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
AB BIOMERIEUX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This submission is for Etest Voriconazole for MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis.
Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.
Device Description
Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.
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