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The Vysis D7S486/CEP 7 FISH Probe Kit is a device intended for specimen characterization, and detects the LSI D7S486 probe target on chromosome 7q31 and the CEP 7 probe target on chromosome 7p11.1-q11.1 in bone marrow and peripheral blood specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this device for diagnosis, prognosis, monitoring or risk assessment has not been established.

The Vysis D7S486/CEP 7 FISH Probe Kit is for specimen characterization and detects the LSI D7S486 (7q31) probe target on chromosome 7q31 and CEP 7 probe target chromosome 7p11.1-q11.1 in bone marrow and peripheral blood specimens. DNA Probe Description Vysis LSI D7S486 SpectrumOrange/ CEP 7 SpectrumGreen Probes: The SpectrumOrange labeled LSI D7S486 probe is approximately 308 kb in length (chr7:115983468-115675366; February 2009 Assembly UCSC Human Genome Browser). The SpectrumGreen labeled CEP 7 probe targets the D7Z1 alpha satellite sequence at the centromere of chromosome 7. The Vysis D7S486/CEP 7 FISH Probe Kit (List No. 04N78-020) consists of a mixture of two DNA FISH probes and four general reagents sufficient to process 20 assays. - . Vysis LSI D7S486 SpectrumOrange/ CEP 7 SpectrumGreen Probes - . Vysis LSI/WCP Hybridization Buffer - . DAPI II Counterstain - NP-40 . - . 20X SSC

The Vysis EGR1 FISH Probe Kit - SC detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. The Vysis EGR1 FISH Probe Kit -SC assay results characterize bone marrow specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this product for diagnosis, monitoring or risk assessment has not been established.

The Vysis EGR1 FISH Probe Kit - Specimen Characterization uses fluorescence in situ hybridization (FISH) DNA probe technology to detect probe target LSI EGR1 (containing early growth response 1 gene; location chromosome 5g31). The LSI D5S23, D5S721 probe (location chromosome 5p15.2) serves as a control. The Vysis EGR1 FISH Probe Kit – SC (List No. 04N37-001) consists of the following components which are sufficient to process 20 assays: 1. Vysis LSI EGR1 SpectrumOrange/D5S23, D5S721 Spectrum Green Probes 2. Vysis LSI/WCP Hybridization Buffer 3. DAPI II Counterstain 4. NP-40 5. 20X SSC Salt Items 2 through 5 above are general purposes reagents. DNA Probes: Vysis LSI EGR1 SpectrumOrange/ D5S23, D5S721 SpectrumGreen. a. The SpectrumOrange-labeled LSI EGR1 probe, approximately 209 kb in length (chr5:137654208-137862738; February 2009 Assembly; UCSC Human Genome Browser) is located at 5g31 and contains the complete EGR1 gene. b. The SpectrumGreen-labeled LSI D5S23, D5S721 probe, approximately 561 kb in length (chr5:9397109-9958407; February 2009 Assembly; UCSC Human Genome Browser) is located at 5p15.2.