ProbeChek PATHVISION HER-2/neu Normal Control Slides

ProbeChek PATHVISION HER
Vysis - 02J05-010

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NTH

Device Name: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.4700

Third Party Flag: N

Medical Specialty: IM

Device Id: 00884999001848

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