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
- 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.
- -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 IdentifiersDevice 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