Poly Rb A-Hu IgM/HRP

GUDID 05700572007364

Polyclonal Rabbit Anti-Human IgM/HRP

Dako Denmark ApS

Total immunoglobulin M (IgM total) IVD, antibody

• Primary Device ID: 05700572007364
• NIH Device Record Key: 16a03288-6b3a-40b3-9d55-3338b8329a61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly Rb A-Hu IgM/HRP
• Version Model Number: P0215
• Company DUNS: 305047466
• Company Name: Dako Denmark ApS
• 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: 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	05700572007364 [Primary]

FDA Product Code

• DEY: IGM, PEROXIDASE, 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: 4
• Public Version Date: 2020-03-13
• Device Publish Date: 2016-09-16

Devices Manufactured by Dako Denmark ApS

• 05700571106938 - FLEX Mono Rb A-Hu Cyclin D1, Cl EP12, RTU (Dako Omnis): 2020-09-25 FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Dako Omnis)
• 05700571107034 - FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis): 2020-09-25 FLEX Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5 Ready-to-Use (Dako Omnis)
• 05700571107041 - FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis): 2020-09-25 FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-Use (Dako Omnis)
• 05700571107065 - FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis): 2020-09-25 FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Dako Omnis)
• 05700571108451 - Artisan Link Pro: 2020-09-25 Artisan Link Pro
• 05700571112571 - Dako CoverStainer: 2020-09-25 Dako CoverStainer
• 05700572013693 - EasyLyse Erythrocyte-Lysing Reagent: 2020-09-25 EasyLyse Erythrocyte-Lysing Reagent
• 05700572000211 - Poly Rb A-Hu Prealbumin: 2020-09-25 Polyclonal Rabbit Anti-Human Prealbumin