GENCHEM™ CK-NAC Reagent GEN-CK R1

GUDID 00851445007136

CK REAGENT 1

GENCHEM INC

Creatine kinase (CK) multiple isoenzyme IVD, reagent
Primary Device ID00851445007136
NIH Device Record Key055abde9-1d22-4694-8b63-59510f8b17e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENCHEM™ CK-NAC Reagent
Version Model NumberGEN-CK R1
Catalog NumberGEN-CK R1
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
GS100851445007136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGSNAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

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™ CK-NAC Reagent]

00851445007143CK REAGENT 2
00851445007136CK REAGENT 1

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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