DEVICE: Ikaros (04250406400003)
Device Identifier (DI) Information
Ikaros
Karyotyping System
In Commercial Distribution
MetaSystems Hard & Software GmbH
Karyotyping System
In Commercial Distribution
MetaSystems Hard & Software GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LNJ | Analyzer, Chromosome, Automated |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K940240 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0274cfb4-0dc7-4825-a4ff-047a2ed14a18
March 10, 2021
4
September 25, 2016
March 10, 2021
4
September 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined