Aperio ePathology IVD System CS2, includes; CS2 IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500

Aperio ePathology IVD System CS2, includes; CS2 IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
eIHC IVD bundle CS2- 2500 - 23CS2IVD-2500

An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NQN

Device Name: Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

Device Class: 2

Physical State: N/A

Definition: Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

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: 864.1860

Third Party Flag: N

Medical Specialty: HE

Device Id: 00815477020051

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