Flow-Set Pro Fluorospheres

Flow
Flow Set Pro (RUO A69184) - A63492

A substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PDX

Device Name: Flow Cytometry Calibrator

Device Class: 2

Physical State: Beads for performing absolute counts of cells in suspension by flow cytometry Beads for standardizing flow cytometers Beads that are used to calibrate fluorescence intensity to quantify ligand binding or fluorogenic assays performed by flow cytometry Beads that are used to perform calibration in addition to quality control of flow cytometric assays. SHOULD NOT INCLUDE beads that are only used for quality control

Definition: Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Bead associated fluorescence or scattered light is used to determine the number of other particles in solution ratio-metrically and to calibrate fluorescence intensity scales on a flow cytometer to standardize measures.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral blood

Regulation Number: 864.5220

Third Party Flag: Y

Medical Specialty: HE

Device Id: 15099590205775

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A