Mono Mo A-Hu CD19/RPE-Cy5, Cl HD37

GUDID 05700572028345

Monoclonal Mouse Anti-Human CD19/RPE-Cy5 Clone HD37

Dako Denmark ApS

CD19 cell marker IVD, antibody

• Primary Device ID: 05700572028345
• NIH Device Record Key: e45586a5-c008-433c-b3da-99ebfe5214f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mono Mo A-Hu CD19/RPE-Cy5, Cl HD37
• Version Model Number: C7066
• 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: false
• 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

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700572028345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980635

FDA Product Code

• GKZ: Counter, differential cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-13
• Device Publish Date: 2016-09-16

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