DEVICE: Cl SOLN (05055273206074)
Device Identifier (DI) Information
Cl SOLN
RX3973
In Commercial Distribution
RX3973
RANDOX LABORATORIES LIMITED
RX3973
In Commercial Distribution
RX3973
RANDOX LABORATORIES LIMITED
Cleaning Solution for the RX series analysers
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 |
---|---|
JJF | Analyzer, Chemistry, Micro, For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K024014 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Once opened the solution is stable for 4 weeks in the absence of contamination when stored at +2°C to +8°C. |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
55a1488e-aa1c-4f94-b0a1-e017ac4e1fb9
July 06, 2018
3
September 26, 2016
July 06, 2018
3
September 26, 2016
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 |
---|---|
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
[?]
+44289445170
technical.services@randox.com
technical.services@randox.com