DEVICE: Idylla™ System (05415219000126)
Device Identifier (DI) Information
Idylla™ System
Idylla™ Console
In Commercial Distribution
P1010
Biocartis NV
Idylla™ Console
In Commercial Distribution
P1010
Biocartis NV
The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System.
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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48031 | Thermal cycler nucleic acid amplification analyser IVD, laboratory |
An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.
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FDA Product Code
[?]Product Code | Product Code Name |
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OOI | Real Time Nucleic Acid Amplification System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
782ca70b-751e-4bb4-8f39-64c4a1e447ac
July 14, 2025
5
August 21, 2017
July 14, 2025
5
August 21, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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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
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No Customer Contact currently defined