URIC ACID-SL Assay 237-60

GUDID 00628063400997

SEKISUI DIAGNOSTICS, LLC

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Primary Device ID	00628063400997
NIH Device Record Key	5c2099dd-0533-4be0-b68f-a6c629892b9e
Commercial Distribution Status	In Commercial Distribution
Brand Name	URIC ACID-SL Assay
Version Model Number	237-60
Catalog Number	237-60
Company DUNS	966812344
Company Name	SEKISUI DIAGNOSTICS, LLC
Device Count	2
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628063400997 [Primary]
GS1	10628063400994 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K961586

FDA Product Code

KNK	Acid, uric, uricase (colorimetric)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-20

On-Brand Devices [URIC ACID-SL Assay]

00628063401000	237-99
00628063400997	237-60