GENCHEM™ Direct Bilirubin Reagent GEN-DBILI R2

GUDID 00851445007204

DIRECT BILIRUBIN R2

GENCHEM INC

Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry
Primary Device ID00851445007204
NIH Device Record Keyc9178956-abe3-43ee-a28a-bad9e2c55b1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENCHEM™ Direct Bilirubin Reagent
Version Model NumberGEN-DBILI R2
Catalog NumberGEN-DBILI 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
GS100851445007204 [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™ Direct Bilirubin Reagent]

00851445007204DIRECT BILIRUBIN R2
00851445007198DIRECT 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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