URIC ACID-SL Assay 237-99

GUDID 00628063401000

SEKISUI DIAGNOSTICS, LLC

Uric acid IVD, kit, enzyme spectrophotometry
Primary Device ID00628063401000
NIH Device Record Key73d282ee-1c35-4bb0-9c5d-2316a189b4fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameURIC ACID-SL Assay
Version Model Number237-99
Catalog Number237-99
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628063401000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNKAcid, uric, uricase (colorimetric)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [URIC ACID-SL Assay]

00628063401000237-99
00628063400997237-60

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.