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510(k) Data Aggregation
K Number
K961623Device Name
FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
Manufacturer
BECTON DICKINSON MONOCLONAL CENTER
Date Cleared
1996-06-07
(42 days)
Product Code
GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON MONOCLONAL CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For flow cytometer set up and monitoring of instrument performance.
The procedure employs a Becton Dickinson flow cytometer and recommended computer hardware and software.
Device Description
Becton Dickinson CaliBRITE 3 Color and FACSComp are intended for use on the Becton Dickinson flow cytometers FACScan™ or FACSort or FACSCalibur™. FACSComp Software and CaliBRITE 3 Color Beads are used to optimally adjust instrument settings, to monitor the sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp Software and CaliBRITE 3 Color Beads are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with three FL channels. FACSComp Software and CaliBRITE 3 Color Beads are used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on thow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. CaliBRITE 3 Color will be provided as a Kit, comprising unstained, FITC, PE and PerCP beads. CaliBRITE PerCP beads will also be provided as a separate product, to be used with CaliBRITE Kits having unstained FITC and PE beads only.
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