Novolink RE7290-K

GUDID 05055331301864

Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novolink™ Polymer and Novolink™ DAB (Polymer) contain component reagents of these systems and are intended for use in the procedure described below.

LEICA BIOSYSTEMS NEWCASTLE LTD

Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Primary Device ID05055331301864
NIH Device Record Key518f7fae-7081-4816-8ff1-33513085884f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovolink
Version Model NumberRE7290-CE
Catalog NumberRE7290-K
Company DUNS397134693
Company NameLEICA BIOSYSTEMS NEWCASTLE LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Customer Support Contacts

Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com
Phone+1(800)2480123
Emailtech.support@leicabiosystems.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055331301864 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by LEICA BIOSYSTEMS NEWCASTLE LTD

05055331300034 - Novocastra™2021-05-03 NCL-L-ZAP-70 is intended for the qualitative identification by light microscopy of ZAP-70 molecules in paraffin sections.
05055331300362 - Novocastra™2021-05-03 NCL-L-VIM-572 is intended for the qualitative identification by light microscopy of Vimentin molecules in paraffin sections.
05055331301864 - Novolink2021-05-03Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novolink™ Polymer and Novolink™ DAB (Polymer) contain component reagents of these systems and are intended for use in the procedure described below.
05055331301864 - Novolink2021-05-03 Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies.
05055331303691 - BOND™2021-05-03 ZAP-70 (L453R) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human ZAP-70
05055331303813 - BOND™2021-05-03 Cytokeratin 19 (b170) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human
05055331303844 - BOND™2021-05-03 Thyroid Stimulating Hormone (QB2/6) monoclonal antibody is intended to be used for the qualitative identification by light micro
05055331303882 - BOND™2021-05-03 Human Growth Hormone (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of huma
05055331304162 - BOND™2021-05-03 Calcitonin (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human calciton

Trademark Results [Novolink]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVOLINK
NOVOLINK
87866852 5606995 Live/Registered
NOVOLINK, INC.
2018-04-06
NOVOLINK
NOVOLINK
87866845 5606994 Live/Registered
NOVOLINK, INC.
2018-04-06
NOVOLINK
NOVOLINK
86781008 not registered Dead/Abandoned
Novolink Holdings Ltd.
2015-10-07
NOVOLINK
NOVOLINK
78275780 not registered Dead/Abandoned
NovoLink Communications, Inc.
2003-07-17
NOVOLINK
NOVOLINK
75610187 not registered Dead/Abandoned
Hidden Oaks Technology Corp.
1998-11-18
NOVOLINK
NOVOLINK
75583797 not registered Dead/Abandoned
Hidden Oaks Technology Corp.
1998-11-18

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