- Physicians Office Resource

Vysis D7S486/CEP 7 FISH Probe Kit
Vysis - 04N78-020

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

Vysis D7S486/CEP 7 FISH Probe Kit must be stored to protect 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

-15.00
-25.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PFG

Device Name: Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders

Device Class: 2

Physical State: DNA probes labeled with fluorescent dyes, hybridization buffers, counterstain

Definition: DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.

Submission Type ID: 1

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Cells from bone marrow or peripheral blood are obtained from a patient with a hematological disorder. Cells are attached to microscope slides using standard cytogenetic procedures. The resulting specimen DNA is denatured to single-stranded form and subsequently allowed to hybridize with ore or more fluorescently labeled DNA probes. Following hybridization, the unbound probe is removed by a series of washes, and the nuclei are counterstained with I, a DNA-specific stain that fluoresces blue. Hybridization of the probe(s) is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, allowing visualization of the fluorescent signals.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Bone marrow and/or peripheral blood specimens

Regulation Number: 864.1870

Third Party Flag: Y

Medical Specialty: HE

Device Identifiers

Device Id: 00884999036406

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

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