TOTAL PROTEIN (MICRO) Assay 450-50

GUDID 00628063400805

SEKISUI DIAGNOSTICS, LLC

Total protein IVD, kit, enzyme spectrophotometry
Primary Device ID00628063400805
NIH Device Record Keya5d45aaf-b10d-4ad5-b331-9b147602066b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOTAL PROTEIN (MICRO) Assay
Version Model Number450-50
Catalog Number450-50
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
GS100628063400805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

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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