DEVICE: BUF WASH (conc.) (05055273202663)

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Device Identifier (DI) Information

BUF WASH (conc.)
EV3581
EV3581
RANDOX LABORATORIES LIMITED
05055273202663
GS1
1
Diluted wash buffer is used for washing the biochips between assay steps to remove all unbound materials.
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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
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
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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C).
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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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