Vysis EGR1 FISH Probe Kit - SC (Specimen Characterization)

Vysis EGR1 FISH Probe Kit
Vysis - 04N37-001

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 acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PDO

Device Name: Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

Device Class: 2

Physical State: May include LSI EGR1 DNA probes, hybridization buffers, DAPI counterstain

Definition: The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist.

Submission Type ID: 1

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Bone marrow cells from AML patients attached to microscope slides using standard cytogenetic procedures are used for this assay. The resulting specimen DNA is denatured to single-stranded form and subsequently allowed to hybridize with the LSI EGR1 and LSI D5S23, D5S721 probes. Following hybridization, the unbound probe is removed by a series of washes, and the nuclei are counterstained with DAPI, a DNA-specific stain that fluoresces blue. Hybridization of the LSI EGR1 and LSI D5S23, D5S721 probes is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, allowing visualization of the orange and green fluorescent signals.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Bone marrow specimens

Regulation Number: 864.1870

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00884999038165

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