Abbott RealTime IDH2 m2000rt Application CD-ROM

Abbott RealTime IDH2 m2000rt Application CD
RealTime - 08N82-001

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).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OWD

Device Name: Somatic Gene Mutation Detection System

Device Class: 3

Physical State: Test consists of reagents, instrumentation, software and instructions needed to perform the test method.

Definition: The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.

Submission Type ID: 2

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: In vitro amplification and detection of genomic DNA representing a somatic gene mutation from a cancerous specimen of interest.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human clinical specimens of peripheral blood or bone marrow.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00884999047037

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