PD-L1 Control Slides

GUDID 05700571112755

PD-L1 Control Slides

AGILENT TECHNOLOGIES, INC.

Programmed death-ligand 1 (PD-L1) IVD, control

• Primary Device ID: 05700571112755
• NIH Device Record Key: 1c81ef19-0ab2-4d2e-b15c-8d5f0aa8f4c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PD-L1 Control Slides
• Version Model Number: T1391
• Company DUNS: 084963177
• Company Name: AGILENT TECHNOLOGIES, INC.
• Device Count: 5
• 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: +1-877-424-4536
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700571112755 [Unit of Use]
GS1	05700573001736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150013

FDA Product Code

• KIR: Cells, Animal And Human, Cultured
• 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: 2021-06-21
• Device Publish Date: 2020-11-17

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• 05700575005244 - PMS2 IHC pharmDx (Dako Omnis): 2025-09-04 PMS2 IHC pharmDx (Dako Omnis)
• 05700575005251 - MMR Negative Control Reagent, Mouse (Dako Omnis): 2025-09-04 MMR Negative Control Reagent, Mouse (Dako Omnis)
• 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