Poly Rb A-Hu IgM

GUDID 05700572001416

Polyclonal Rabbit Anti-Human IgM

Dako Denmark ApS

Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody Total immunoglobulin M (IgM total) IVD, antibody

• Primary Device ID: 05700572001416
• NIH Device Record Key: 92bf4953-0e09-4422-bfb8-2ff447e61871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly Rb A-Hu IgM
• Version Model Number: A0426
• 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: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter

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	05700572001416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K812487

FDA Product Code

• DAO: IGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL

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

On-Brand Devices [Poly Rb A-Hu IgM]

• 05700572001416: Polyclonal Rabbit Anti-Human IgM
• 05700572001409: Polyclonal Rabbit Anti-Human IgM