DEVICE: IDS-iSYS Multi Discipline Automated System (05060169691223)
Device Identifier (DI) Information
IDS-iSYS Multi Discipline Automated System
IS-310400
In Commercial Distribution
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-310400
In Commercial Distribution
IMMUNODIAGNOSTIC SYSTEMS LIMITED
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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56676 | Multiple clinical chemistry analyser IVD, laboratory |
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.
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FDA Product Code
[?]Product Code | Product Code Name |
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JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K091849 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Special Storage Condition, Specify: The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months |
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
afed2d37-23a8-4c48-94dd-f40dfb59325a
January 15, 2024
6
April 01, 2016
January 15, 2024
6
April 01, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401915190660
techsupport.uk@idsplc.com
techsupport.uk@idsplc.com