PAX-8 (SP348) Rabbit Monoclonal Antibody 10272589001

GUDID 07613336231395

Ventana Medical Systems, Inc.

Paired box protein (PAX) IVD, antibody

• Primary Device ID: 07613336231395
• NIH Device Record Key: 6391eacf-3349-4d1e-a60d-bc3bb7541392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAX-8 (SP348) Rabbit Monoclonal Antibody
• Version Model Number: 10272589001
• Catalog Number: 10272589001
• Company DUNS: 184042521
• Company Name: Ventana Medical Systems, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336231395 [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: 2026-02-24
• Device Publish Date: 2026-02-16

Devices Manufactured by Ventana Medical Systems, Inc.

• 07613336231395 - PAX-8 (SP348) Rabbit Monoclonal Antibody: 2026-02-24
• 07613336231395 - PAX-8 (SP348) Rabbit Monoclonal Antibody: 2026-02-24
• 04015630971008 - Antibody Diluent: 2025-12-23
• 04015630971176 - Bluing Reagent: 2025-12-23
• 04015630971299 - Amplification Kit: 2025-12-23
• 04015630971367 - Alcian Blue Staining Kit: 2025-12-23
• 04015630971374 - Alcian Blue for PAS: 2025-12-23
• 04015630971404 - Giemsa Staining Kit: 2025-12-23
• 04015630971411 - Iron Staining Kit: 2025-12-23