Dako

GUDID 05700572013853

Cystatin C Immunoparticles

Dako Denmark ApS

Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody Cystatin C IVD, antibody

• Primary Device ID: 05700572013853
• NIH Device Record Key: d9e82626-5647-415e-9b23-a06a0ac1b040
• Commercial Distribution Discontinuation: 2018-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Dako
• Version Model Number: LX002
• 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: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 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	05700572013853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041627

FDA Product Code

• JIT: CALIBRATOR, SECONDARY

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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• 05700572027805: Monoclonal Mouse Anti-Human CD30 Clone Ber-H2
• 05700572014294: Cystatin C Calibrator
• 05700572013853: Cystatin C Immunoparticles
• 05700572013334: Monoclonal Mouse Anti-Human CD20cy Clone L26
• 05700572010111: Polyclonal Rabbit Anti- S100
• 05700572005278: Monoclonal Mouse Anti-Human CD20cy Clone L26
• 05700572005209: Monoclonal Mouse Anti-Human CD30 Clone Ber-H2
• 05700572005100: Monoclonal Mouse Anti-Human CD45R0 Clone UCHL1
• 05700572004653: Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen Clones 2B11 + PD7/26
• 05700571107027: FLEX Monoclonal Mouse Anti-Myogenin Clone F5D Ready-to-Use (Dako Omnis)