CGH Hybridization Reagents

CGH Hybridization Reagents
Vysis - 06J40-010

A collection of reagents and other associated materials intended to be used for the detection of nucleic acid (e.g., DNA, RNA) probes [not included] hybridized to their target nucleotide sequences in a clinical specimen. It may be based on different techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH), or line probe assay (LPA)] and is used to detect and localize the presence or absence of specific nucleic acid sequences.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PPM

Device Name: General Purpose Reagent

Device Class: 1

Physical State: N/A

Definition: A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

Submission Type ID: 4

Review Panel: PA

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Diagnostic

Regulation Number: 864.4010

Third Party Flag: N

Medical Specialty: PA

Device Id: 00884999020184

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