DEVICE: URIC ACID-SL Assay (00628063400997)

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Device Record History
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Device Identifier (DI) Information
URIC ACID-SL Assay
237-60
In Commercial Distribution
237-60
SEKISUI DIAGNOSTICS, LLC
00628063400997
GS1

2
966812344 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
53583 Uric acid IVD, kit, spectrophotometry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of uric acid in a clinical specimen, using a spectrophotometry method.
Active false
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FDA Product Code

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Product Code Product Code Name
KNK Acid, uric, uricase (colorimetric)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K961586 000
No CLOSE

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
5c2099dd-0533-4be0-b68f-a6c629892b9e
April 04, 2023
4
September 20, 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: 10628063400994 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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No Customer Contact currently defined
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