DEVICE: UREA (05055273206869)

Device Identifier (DI) Information

UREA
UR221
In Commercial Distribution
UR221
RANDOX LABORATORIES LIMITED
05055273206869
GS1

1
227530649 *Terms of Use
This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.
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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
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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FDA Product Code

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Product Code Product Code Name
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K923506 000
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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: Once reconstituted it is stable for 4 weeks at +2 to +8°C or 2 days at +15 to +25°C.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9d9e396e-d1fe-4537-b9b2-1a3678b711c6
July 06, 2018
4
September 24, 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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+442894451070
technical.services@randox.com
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