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510(k) Data Aggregation
K Number
K954923Device Name
BACTEC FUNGAL MEDIUM
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-11-21
(392 days)
Product Code
JTA
Regulation Number
866.2560Why did this record match?
Product Code :
JTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Qualitative culture and recovery of yeasts and fungi from blood
Device Description
BACTEC Fungal Medium is a growth medium providing an aerobic environment for the detection of yeast and fungi. It has been designed for blood volumes of four to 10 mL, and is used specifically with BACTEC non-radiometric (NR) series instruments in the monitoring of clinical blood specimens for the presence of yeasts and fungi. BACTEC Fungal medium has a higher weight/volume concentration of dextrose and sucrose then the predicate device to enhance the recovery and CO2 production of yeast. Saponin was added to the BACTEC Fungal Medium as a lysing agent, and ferric ammonium citrate was added as a source of iron to stimulate recovery of fungi other than yeast. Resin was removed from this medium. Principles for detection of CO2 produced by microorganisms metabolizing blood culture medium nutrients are identical to the predicate device.
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