Vysis CLL FISH Probe Kit

Vysis CLL FISH Probe Kit
Vysis - 04N02-021

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 chronic lymphocytic leukaemia (CLL) based on changes at the gene or chromosomal level, which may involve genetic markers on chromosomes 11, 12, 13 and 17.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PNK

Device Name: Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

Device Class: 3

Physical State: Probe Kit consists of slide preparation materials, fluorescent FISH probes, buffers and nuclear counterstain, followed by manual signal enumeration using a fluorescence-enabled microscope.

Definition: A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).

Submission Type ID: 2

Review Panel: MG

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The assay uses fluorescence in situ hybridization to identify a deletion in chromosome 17 at the TP53 gene locus in peripheral blood from CLL Patients.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral blood

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00884999042780

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