DEVICE: CREA (05055273201888)

Device Identifier (DI) Information

CREA
CR2804
In Commercial Distribution
CR2804
RANDOX LABORATORIES LIMITED
05055273201888
GS1

1
227530649 *Terms of Use
The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic device intended for the quantitative 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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

aa4e63c2-0702-4569-9673-10a8b0ada673
December 20, 2022
4
September 16, 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)

[?]
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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