GENCHEM™ Total Bilirubin Reagent GEN-TBILI R2

GUDID 00851445007273

TOTAL BILIRUBIN R2

GENCHEM INC

Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry Total bilirubin IVD, kit, enzyme spectrophotometry
Primary Device ID00851445007273
NIH Device Record Key9e3b9d75-7e4a-432b-ac05-9d5615b7b637
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENCHEM™ Total Bilirubin Reagent
Version Model NumberGEN-TBILI R2
Catalog NumberGEN-TBILI R2
Company DUNS193856866
Company NameGENCHEM INC
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org
Phone+1(714)529-7125
Emaillorlow@genchem.org

Device Identifiers

Device Issuing AgencyDevice ID
GS100851445007273 [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 Date2016-09-19

On-Brand Devices [GENCHEM™ Total Bilirubin Reagent]

00851445007280TOTAL BILIRUBIN R3
00851445007273TOTAL BILIRUBIN R2
00851445007266TOTAL BILIRUBIN R1

Trademark Results [GENCHEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENCHEM
GENCHEM
76171200 not registered Dead/Abandoned
Novasite Pharmaceuticals, Inc.
2000-11-22

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