Vysis CEP X SpectrumOrange/ Y SpectrumGreen
Vysis - 07J20-050
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 unopened CEP X/Y DNA probe kit as a unit protected from light and humidity. The 20X SSC salts and NP-40 may be stored separately at room temperature.
- -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: 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
Code: OXP
Device Name: Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
Device Class: 2
Physical State: Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders
Definition: X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.
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: opposite-sex bone marrow transplantation for hematological disorders
Regulation Number: 866.6010
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 00884999027022
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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