CEP 8 SpectrumOrange
Vysis - 07J22-008
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 evaluate a clinical specimen to diagnose, monitor or predict one or multiple acquired aneuploidies associated with cancer, such as aneuploidies of chromosome 3, 7, and 17 (associated with bladder cancer) or chromosome 8 and 12 [associated with B-cell chronic lymphocytic leukaemia (CLL) and myeloid disorders such as chronic myeloid leukaemia (CML) and acute myeloid leukaemia (AML)], in a clinical specimen.
Environmental Conditions
- Store the probe kit as a unit protected from light and humidity. After preparation store 20X SCC salts and NP-40 component solutions at room temperature up to 6 months.
- -20.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OYU
Device Name: Dna-Probe Kit, Human Chromosome
Device Class: 2
Physical State: Reagents for identifying and enumerating human chromosomes
Definition: Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.
Submission Type ID: 1
Review Panel: PA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: fluorescence in situ hybridization (FISH)
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: human cells
Regulation Number: 866.4700
Third Party Flag: N
Medical Specialty: IM
Code: KIR
Device Name: Cells, Animal And Human, Cultured
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: PA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.2280
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 00884999027077
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