Vysis ALK Break Apart FISH Probe Kit

Vysis ALK Break Apart FISH Probe Kit
Vysis - 06N38-053

A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict genetic mutations of the anaplastic lymphoma kinase (ALK) gene, also known as ALK gene. The changes detected at the gene or chromosome level may include ALK gene rearrangement, or NPM-ALK or EML4-ALK fusion genes formed by translocation.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OWE

Device Name: Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Device Class: 3

Physical State: Probe and accessory assay kits contains pre-treatment solution, ALK dual color break apart probe mix, buffers, counter stain, and fluorescence mounting medium

Definition: Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs.

Submission Type ID: 2

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Fluorescence in situ hybridization.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Formalin-fixed, paraffin-embedded human non-small cell lung cancer tissue specimen

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00884999042773

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