Vysis CEP X SpectrumOrange/ Y SpectrumGreen

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
Vysis - 07J20-050

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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