Abbott RealTime IDH2 Amplification Reagent Kit

Abbott RealTime IDH2 Amplification Reagent Kit
RealTime - 08N82-090

A collection of reagents and other associated materials intended to be used to diagnose, monitor or predict the isocitrate dehydrogenase 2 (IDH2) gene mutation status of a clinical specimen, using a nucleic acid technique (NAT). Mutations of the IDH2 gene are commonly found in cases of glioma and acute myeloid leukaemia (AML).

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: 00884999047044

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