ORTHO Optix™ Reader ID-MTS Gel

ORTHO Optix™ Reader ID
ORTHO - 6842222

An electrically-powered laboratory instrument designed to be used to capture digital images of a clinical specimen from a dedicated specimen slide/cartridge/card and provide image analysis of an agglutination or haemagglutination assay. It is a benchtop instrument that includes a tray, slot or drawer, where the specimen is placed for optical image acquisition, and dedicated software for analysis, visualization and storage of the acquired images.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KSZ

Device Name: System, Test, Automated Blood Grouping And Antibody

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

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: 864.9175

Third Party Flag: N

Medical Specialty: HE

Device Id: 10758750032846

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