DEVICE: CREA (05055273208634)

Device Identifier (DI) Information

CREA
CR8316
In Commercial Distribution
CR8316
RANDOX LABORATORIES LIMITED
05055273208634
GS1

1
227530649 *Terms of Use
The is intended for the quantitative in vitro diagnostic determination of Creatinine 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

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
53252 Creatinine IVD, reagent
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CGX Alkaline Picrate, Colorimetry, Creatinine
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K973993 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Once opened and capped stable for 21 days when stored at 2-8°C
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

cee7bf8a-9faa-4124-be48-ae3c31dca380
December 20, 2022
4
September 16, 2016
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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
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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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+442894451070
technical.services@randox.com
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