- Physicians Office Resource

NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
Navios EX - TETRA SOFTWARE V2.0 NEW USER

Device Description

An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

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: 15099590683276

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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