GLUCOSE SK235-10

GUDID 00628063400539

SEKISUI DIAGNOSTICS, LLC

Glucose IVD, kit, enzyme spectrophotometry
Primary Device ID00628063400539
NIH Device Record Key0113a1e4-349f-41a4-ba1c-257d1b75a350
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLUCOSE
Version Model NumberSK235-10
Catalog NumberSK235-10
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count2
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
GS100628063400539 [Primary]
GS110628063400536 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CFRHEXOKINASE, GLUCOSE

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

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

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00628063401321 - Alinity c Acetaminophen Calibrator2023-05-16
10742860100397 - OSOM ULTRA PLUS FLU A&B Test 2022-06-10
00628063401222 - DC-TROL LEVELS 1 & 22020-04-07
00628063400003 - Carbon Dioxide L3K2019-10-21
00628063400287 - CARBON DIOXIDE L3K Assay2019-10-21

Trademark Results [GLUCOSE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLUCOSE
GLUCOSE
78764828 not registered Dead/Abandoned
Glucose Media, Inc.
2005-12-01

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