DIRECT BILIRUBIN-SL Assay 247-30

GUDID 00628063400164

SEKISUI DIAGNOSTICS, LLC

Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Primary Device ID00628063400164
NIH Device Record Key43b16ad1-72e8-46cf-84da-6a3b1afba33f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECT BILIRUBIN-SL Assay
Version Model Number247-30
Catalog Number247-30
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
GS100628063400164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CIGDIAZO COLORIMETRY, BILIRUBIN

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

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