Vysis EGR1 FISH Probe Kit

Vysis EGR1 FISH Probe Kit
Vysis - 04N37-020

Device Description

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).

Environmental Conditions

Special Storage Condition, Specify

Kit must be protected from light when not in use. The NP-40 and 20X SSC Salt may be stored separately at room temperature.

Storage Environment Temperature - Degrees Celsius

-10.00
-30.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OWK

Device Name: Early Growth Response 1 (Egr) Fish Probe Kit

Device Class: 2

Physical State: Device is a kit containing labeled FISH Probes

Definition: The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.

Submission Type ID: 1

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Detection of Early Growth Response Gene (EGR1) by fluorescence in-situ hybridization.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not applicable

Regulation Number: 866.6040

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 00884999008366

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