Ikaros

Primary DI
04250406400003
Brand
Ikaros
Company
MetaSystems Hard & Software GmbH
Model
Karyotyping System
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LNJAnalyzer, Chromosome, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNJAnalyzer, Chromosome, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940240000IKAROSMetasystems GmbH1995-02-24LNJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250406400003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250406400003042504064000034250406400003

GMDN Terms#

Term, Definition table
TermDefinition
Karyotyping cell-image analyserAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329631642
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250406401000NeonMedical Device Data System2023-07-10
04250406460007MetaferMicroscopic image acquisition2023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.LNJ2024-07-02
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.LNJ2022-03-21
07290016630015GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.LNJ2018-01-25
07290016630008GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.LNJ2017-01-12