COULTER PrepPlus 2

COULTER PrepPlus 2
PrepPlus 2 - 378600

An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

No Data Available

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: 15099590638191

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