DEVICE: L SOLN (05055273214888)

Device Identifier (DI) Information

L SOLN
D400-0018
In Commercial Distribution
D400-0018
RANDOX LABORATORIES LIMITED
05055273214888
GS1

1
227530649 *Terms of Use
Used as a Calibrator in a two-point calibration. L Solution is pumped into the sample port by the L Solution pump and then positioned in front of the sensor.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
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
Multiple clinical chemistry analyte IVD, calibrator A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131554 000
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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
Special Storage Condition, Specify: Once opened L Solution is stable for 1 month at +15 to +25°C.
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f62183a9-89a8-410f-a1d8-b01dc46fd3ca
July 06, 2018
3
September 26, 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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Yes
No
Yes
No
No CLOSE

Customer Contact

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+44289445170
technical.services@randox.com
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