DEVICE: SOLN WASH (05055273210361)

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Device Identifier (DI) Information

SOLN WASH
RX4003
RX4003
RANDOX LABORATORIES LIMITED
05055273210361
GS1
1
This should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning solution may be aspirated from a sample cup but the cup must be covered between use to eliminate evaporation and ensure accuracy.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Wash/cleaning solution IVD, automated/semi-automated system A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
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FDA Product Code

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Product Code Product Code Name
JJF Analyzer, Chemistry, Micro, 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
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
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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
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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