DEVICE: IDS-iSYS Multi Discipline Automated System (05060169691223)

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Device Identifier (DI) Information

IDS-iSYS Multi Discipline Automated System
IS-310400

IMMUNODIAGNOSTIC SYSTEMS LIMITED
05060169691223
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multichannel clinical chemistry analyser IVD, laboratory, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using more two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
April 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No
No CLOSE

Customer Contact

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+4401915190660
techsupport.uk@idsplc.com
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