Ikaros

Basic Information

• Brand Name: Ikaros
• Primary DI: 04250406400003
• Version / Model: Karyotyping System
• Company Name: MetaSystems Hard & Software GmbH
• Labeler DUNS: 329631642
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-25
• Public Version: 4
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 0274cfb4-0dc7-4825-a4ff-047a2ed14a18

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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: No
• 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
LNJ	Analyzer, Chromosome, Automated	Hematology	864.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33936	Karyotyping cell-image analyser IVD	An automated laboratory instrument designed for analysis of cell images, either directly from cell preparations (e.g., smears) or from cell images obtained from other devices (e.g., microscopes), that can identify and classify abnormalities in the chromosome (e.g., translocations). It usually provides results as a graphic (karyotype) normally applied for the pre and postnatal diagnosis of birth defects, chromosomal abnormalities, genetic disorders (e.g., Down syndrome), cancer, and cancer treatment follow up. The device typically includes display, recording, and communication capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250406400003	GS1

Premarket Submissions

Submission Number	Supplement Number
K940240	000