CEP 12 SpectrumOrange

CEP 12 SpectrumOrange
Vysis - 07J22-012

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 be used to evaluate a clinical specimen to diagnose, monitor or predict chronic lymphocytic leukaemia (CLL) based on changes at the gene or chromosomal level, which may involve genetic markers on chromosomes 11, 12, 13 and 17.

Environmental Conditions

Special Storage Condition, Specify

Store unopened probe kit protected from light and humidity. Store 20X SSC salts and NP - 40 at room temperature. Store Slides in a sealed container with desiccant protected from humidity.

Storage Environment Temperature - Degrees Celsius

-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: 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

Device Identifiers

Device Id: 00884999027084

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