ANTI-MELANOMA ASSOCIATED ANTIGEN AM077-5M

GUDID 00810119672988

BIOGENEX LABORATORIES

Melanoma-associated antigen (MAGE) IVD, antibody

• Primary Device ID: 00810119672988
• NIH Device Record Key: 7752f7ed-4f56-4495-9532-8128aacba0b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTI-MELANOMA ASSOCIATED ANTIGEN
• Version Model Number: AM077-5M
• Catalog Number: AM077-5M
• Company DUNS: 042697045
• Company Name: BIOGENEX LABORATORIES
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810119672988 [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: 2023-04-18
• Device Publish Date: 2023-04-10

On-Brand Devices [ANTI-MELANOMA ASSOCIATED ANTIGEN]

• 00810119672988: AM077-5M
• 00810119676085: MU077-UC