Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit

Vysis Paraffin Pretreatment IV & Post
Vysis - 01N31-005

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

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: 00884999000735

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