The RANDOX evidence® system is a fully automated, continuous access immunoanalyser using protein biochip array technology. It is intended for the in-vitro qualitative, semi-quantitative or fully quantitative determination of various diagnostic markers.

The RANDOX evidence® system is a fully automated, continuous access immunoanalyser using protein biochip array technology. It is intended for the in
Randox Evidence™ - EV3600

A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software. It operates with minimal technician involvement and complete automation of all procedural steps.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJE

Device Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.2160

Third Party Flag: N

Medical Specialty: CH

Device Id: 05055273214024

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