MAGE-A4 IHC 1F9 pharmDx

GUDID 05700573007400

MAGE-A4 IHC 1F9 pharmDx

AGILENT TECHNOLOGIES, INC.

Melanoma-associated antigen (MAGE) IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 05700573007400
• NIH Device Record Key: 9c30af27-07a0-4aea-92f2-df2c723166fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGE-A4 IHC 1F9 pharmDx
• Version Model Number: SK032
• 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: +1-800-227-9770
• 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

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700573007400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230016

FDA Product Code

• SBL: Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

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: 2024-10-09
• Device Publish Date: 2024-10-01

Devices Manufactured by AGILENT TECHNOLOGIES, INC.

• 05700573007400 - MAGE-A4 IHC 1F9 pharmDx: 2024-10-09MAGE-A4 IHC 1F9 pharmDx
• 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
• 05700571112311 - Dako: 2024-08-15 Dako Omnis Small Vial, 2 mL
• 05700571112328 - Dako: 2024-08-15 Dako Omnis Large Vial, 30 mL
• 05700574037420 - SureFISH 13q14.2 RB1 522kb P20 GR: 2024-06-17 SureFISH 13q14.2 RB1 522kb P20 GR
• 05700574007164 - 406FX-SI: 2023-04-04 Microplate Washer Dispenser
• 05700574034320 - BSTCK2WR-SI: 2023-04-04 Microplate Stacker
• 05700574034337 - BSTCK3WR-SI: 2023-04-04 Microplate Stacker