FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link)

GUDID 05700571106907

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a Clone EP1 Ready-to-Use (Link)

Dako North America, Inc.

Estrogen (oestrogen)/progesterone receptor IVD, antibody

• Primary Device ID: 05700571106907
• NIH Device Record Key: 447ce70e-fd24-4ca5-8993-f08a7cd7ae8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link)
• Version Model Number: IR084
• 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: 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700571106907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120663

FDA Product Code

• MYA: IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-24
• Device Publish Date: 2016-09-16

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