ALBUMIN Assay 200-45

GUDID 00628063400065

SEKISUI DIAGNOSTICS, LLC

Albumin IVD, kit, spectrophotometry
Primary Device ID00628063400065
NIH Device Record Key9a4fc92b-dc34-439b-8ea3-65b0f1b9e80f
Commercial Distribution StatusIn Commercial Distribution
Brand NameALBUMIN Assay
Version Model Number200-45
Catalog Number200-45
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count4
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
GS100628063400065 [Primary]
GS110628063400062 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CIXBROMCRESOL GREEN DYE-BINDING, ALBUMIN

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 Date2016-09-16

On-Brand Devices [ALBUMIN Assay]

00628063400065200-45
00628063400058200-05

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