Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

GUDID 05700573004591

Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

AGILENT TECHNOLOGIES, INC.

Ki67 antigen IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 05700573004591
• NIH Device Record Key: cf67f102-7090-4bc1-8352-8bb8791f5843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
• Version Model Number: GE020
• Company DUNS: 084963177
• Company Name: AGILENT TECHNOLOGIES, 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: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com

Device Dimensions

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700573004591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210026

FDA Product Code

• QQT: Immunohistochemistry assay, antibody, Ki-67

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: 2021-10-27
• Device Publish Date: 2021-10-19

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• 05700575005268 - MMR Negative Control Reagent, Rabbit (Dako Omnis): 2025-09-04 MMR Negative Control Reagent, Rabbit (Dako Omnis)
• 05700573007400 - MAGE-A4 IHC 1F9 pharmDx: 2024-10-09 MAGE-A4 IHC 1F9 pharmDx
• 05700571112342 - Dako: 2024-08-15 Dako Omnis Vial with Mixing Ball, 2 mL