ORTHO

Basic Information

• Brand Name: ORTHO
• Primary DI: 10758750032846
• Version / Model: 6842222
• Catalog Number: 6842222
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 068715424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-07
• Public Version: 2
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: ad012eaa-a42f-42f4-aa74-60ac5630dae9

Device Description

ORTHO Optix™ Reader ID-MTS Gel

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSZ	SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY	Hematology	864.9175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64179	Agglutination assay digital imaging reader/analyser IVD	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750032846	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -23.3 – 65.5 Degrees Celsius