DEVICE: UREA (05055273206920)
Device Identifier (DI) Information
UREA
UR446
In Commercial Distribution
UR446
RANDOX LABORATORIES LIMITED
UR446
In Commercial Distribution
UR446
RANDOX LABORATORIES LIMITED
This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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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? |
---|---|---|---|---|
53590 | Urea IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K923506 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Once reconstituted it is stable for 4 weeks at +2 to +8°C or 2 days at +15 to +25°C. |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9c4712ee-72c7-4b1e-a271-e6a2ec78d2d1
July 06, 2018
4
September 24, 2016
July 06, 2018
4
September 24, 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 |
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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