MAS Bilirubin Liquid Assayed Bilirubin Control

GUDID 00884883003866

Microgenics Corporation

Total bilirubin IVD, control
Primary Device ID00884883003866
NIH Device Record Key3c56de96-cd14-42e6-8ed2-634ae0323568
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Bilirubin Liquid Assayed Bilirubin Control
Version Model NumberBC-S1
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883003866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-30
Device Publish Date2017-04-26

On-Brand Devices [MAS Bilirubin Liquid Assayed Bilirubin Control]

00884883003866BC-S1
00884883003859BC103
00884883003842BC102

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