DEVICE: SAL (05055273209396)

Device Identifier (DI) Information

SAL
SAL4024
In Commercial Distribution
SAL4024
RANDOX LABORATORIES LIMITED
05055273209396
GS1

1
227530649 *Terms of Use
For the quantitative in vitro determination of Salicylate in human serum
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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
Salicylate 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 salicylate in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
DKJ Colorimetry, Salicylate
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K882038 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
Special Storage Condition, Specify: Once open, the reagent is stable for 28 days on board the instrument at approximately 10°C. Do not freeze.
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

b38f247a-802f-4277-a749-70993244bb59
July 06, 2018
3
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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