FLEX Mono Mo A-Hu Cytokeratin HMW High Molecular Weight Cl 34ßE12 RTU

GUDID 05700571101797

FLEX Monoclonal Mouse Anti-Human Cytokeratin HMW High Molecular Weight Clone 34ßE12 Ready-to-Use (Dako Autostainer/ Autostainer Plus)

Dako North America, Inc.

Cytokeratin IVD, antibody

• Primary Device ID: 05700571101797
• NIH Device Record Key: 6ec32bfd-ce76-4a99-9182-8e08506390ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEX Mono Mo A-Hu Cytokeratin HMW High Molecular Weight Cl 34ßE12 RTU
• Version Model Number: IS051
• Company DUNS: 099999732
• Company Name: Dako North America, Inc.
• 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: +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: +1-805-566-6655
• 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

Device Dimensions

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• Device Size Text, specify: 0
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700571101797 [Primary]

FDA Product Code

• NJT: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-25
• Device Publish Date: 2020-09-17

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