ProbeChek Prenatal Positive Control Slides

ProbeChek Prenatal Positive Control Slides
Vysis - 05J36-005

A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple congenital aneuploidies, including (but not limited to) trisomy 13 (Pätau syndrome), trisomy 18 (Edwards syndrome), trisomy 21 (Down syndrome), and sex chromosome aneuploidies.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Device Id: 00884999011663

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