HercepTest™ for the Dako Autostainer

GUDID 05700572031994

HercepTest for the Dako Autostainer

Dako Denmark ApS

C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 05700572031994
• NIH Device Record Key: d58678d3-2469-46a9-b4e6-7f22e757157b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HercepTest™ for the Dako Autostainer
• Version Model Number: K5207
• Company DUNS: 305047466
• Company Name: Dako Denmark ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com
• Phone: +4544859500
• Email: dako.dkregulatory@agilent.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700572031994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980018

FDA Product Code

• MVC: System, Test, Her-2/Neu, Ihc

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-13
• Device Publish Date: 2014-09-15

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