For In Vitro Diagnostic Use
The Vysis CEP 12 SpectrumOrange DNA Probe Kit is a SpectrumOrange labeled probe specific for the alpha satellite (centromeric) region of chromosome 12 (12p11.1-q11).
Vysis CEP 12 SpectrumOrange DNA Probe Kit Package Insert (PDF – 2.2 MB)
For Information Only - Not a Controlled Copy
The CEP 12 SpectrumOrange DNA Probe Kit is intended to detect AT rich alpha satellite sequences in the centromere region of chromosome 12 in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosome 12 via fluorescence in situ hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B-cell chronic lymphocytic leukemia (CLL). It is not intended to be used as a stand alone assay for test reporting; FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, using the same patient specimen. The CEP 12 assay has not been validated for purposes other than those described above. It is not intended for use with test matrices other than peripheral blood lymphocytes from subjects with CLL, to screen for chromosome 12 aneuploidy, eg, in asymptomatic individuals, or to monitor patients for residual disease.
CEP 12 SpectrumOrange DNA Probe Kit Contents
This kit contains:
The CEP 12 SpectrumOrange DNA Probe Kit is available in two configurations: with control slides (07J22-12) and without (07J20-12).
Control slides for the CEP 12 kit are also sold separately. See Order No. 07J21-001, Order No. 07J21-002.
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.
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