The Sample Preparation System PS-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

The Sample Preparation System PS
Sample Preparation System PS-10 - PS-10

An electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PER

Device Name: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Device Class: 1

Physical State: May include automated processing devices, pipetting devices, diluting devices.

Definition: Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Workstations prepare human specimens for flow cytometric analysis using an automated process to aspirate and dispense whole blood, lysing, stabilizing and fixative reagents, along with monoclonal antibodies and florescent molecules.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: May include peripheral whole blood specimens, isolated mononuclear cells, bone marrow, body fluids and cells dispersed from tissues.

Regulation Number: 862.2750

Third Party Flag: N

Medical Specialty: CH

Device Id: 04987562501908

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