DEVICE: ALKALINE WASH SOLUTION (WASH soln. 9) (05055273215007)
Device Identifier (DI) Information
ALKALINE WASH SOLUTION (WASH soln. 9)
RX8130
In Commercial Distribution
RX8130
RANDOX LABORATORIES LIMITED
RX8130
In Commercial Distribution
RX8130
RANDOX LABORATORIES LIMITED
Alkaline Wash Solution should be used in conjunction with reagents to clean cuvettes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
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? |
---|---|---|---|---|
59058 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
da2c85de-2966-4b24-bbb0-dbc4c8f396c3
October 03, 2022
1
September 23, 2022
October 03, 2022
1
September 23, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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
[?]
+442894451070
technical.services@randox.com
technical.services@randox.com