Triglycerides/Glycerol Blanked 05976006190

GUDID 04015630928125

Roche Diagnostics GmbH

Triglyceride IVD, kit, enzyme spectrophotometry
Primary Device ID04015630928125
NIH Device Record Keyed1a61aa-be9e-470b-8073-e3f90b13e19a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriglycerides/Glycerol Blanked
Version Model Number5976006190
Catalog Number05976006190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630928125 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-16
Device Publish Date2021-02-08

On-Brand Devices [Triglycerides/Glycerol Blanked]

0401563099236211877771216
040156309281255976006190

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