TRIGLYCERIDE SK236-10

GUDID 00628063400911

SEKISUI DIAGNOSTICS, LLC

Triglyceride IVD, kit, enzyme spectrophotometry
Primary Device ID00628063400911
NIH Device Record Key67c8702c-6fc2-4c3f-bab8-d02f1f1eaf0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIGLYCERIDE
Version Model NumberSK236-10
Catalog NumberSK236-10
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
GS100628063400911 [Primary]
GS110628063400918 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDTLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

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

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