PathVysion HER-2 DNA Probe Kit

PathVysion HER
PathVysion - 02J01-030

A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is 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: MVD

Device Name: System, Test, Her-2/Neu, Nucleic Acid Or Serum

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00884999001732

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