ProbeChek Positive Control 10% Trisomy 8/12

ProbeChek Positive Control 10% Trisomy 8/12
Vysis - 07J21-002

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: OVQ

Device Name: Chronic Lymphocytic Leukemia Fish Probe Kit

Device Class: 2

Physical State: Reagents for B-cell chronic lymphocytic leukemia prognosis

Definition: The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.

Submission Type ID: 1

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Fluorescent in situ hybridization

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: B-cell chronic lymphocytic leukemia

Regulation Number: 866.6040

Third Party Flag: Y

Medical Specialty: IM

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 Id: 00884999027046

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