COULTER PrepPlus 2
PrepPlus 2 - 378600
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice 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