- Physicians Office Resource

Navios Flow Cytometer
Navios - 6 Color 2 lasers

Device Description

A mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

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: OYE

Device Name: Flow Cytometric Reagents And Accessories.

Device Class: 2

Physical State: May include flow cytometers, monoclonal antibodies, lysis reagents, processing reagents, automated processing devices or pipetting devices.

Definition: To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Particles in suspension may be treated with fluorescent conjugated antibodies or fluorogenic compounds followed by interrogation in a flow cytometer that enumerates and characterizes each particle based on its physical and fluorescent characteristics.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral whole blood specimens, lymphoid biopsies, and neoplastic tissues.

Regulation Number: 864.5220

Third Party Flag: Y

Medical Specialty: HE

Device Identifiers

Device Id: 15099590514730

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

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