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

• Primary Device ID: 05055331301864
• NIH Device Record Key: 518f7fae-7081-4816-8ff1-33513085884f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novolink
• Version Model Number: RE7290-CE
• Catalog Number: RE7290-K
• Company DUNS: 397134693
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055331301864 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-03
• Device Publish Date: 2021-04-23

On-Brand Devices [Novolink]

• 05055331301864: Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and
• 05055331301925: Novolink Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and ra
• 05055331301901: Novolink Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and ra
• 05055331301888: Novolink Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and ra