PD-L1 IHC 28-8 pharmDx

GUDID 05700571108161

PD-L1 IHC 28-8 pharmDx

Dako North America, Inc.

Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 05700571108161
• NIH Device Record Key: 980bf2f0-ac43-4952-abf7-6acfaf704616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PD-L1 IHC 28-8 pharmDx
• Version Model Number: SK005
• Company DUNS: 099999732
• Company Name: Dako North America, Inc.
• 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: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-805-566-6655
• Email: dako.usregulatory@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com
• Phone: +1-800-227-9770
• Email: Global.RA@agilent.com

Device Dimensions

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

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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700571108161 [Primary]

FDA Product Code

• PLS: Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-13

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