CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody 05278406001

GUDID 04015630972241

Ventana Medical Systems, Inc.

Estrogen (oestrogen)/progesterone receptor IVD, antibody

• Primary Device ID: 04015630972241
• NIH Device Record Key: e3b9b946-528b-410a-b49d-4a42da2fff09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody
• Version Model Number: 50 tests
• Catalog Number: 05278406001
• Company DUNS: 184042521
• Company Name: Ventana Medical Systems, 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: 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	04015630972241 [Primary]

FDA Product Code

• MYA: IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-07-08
• Device Publish Date: 2015-12-31

On-Brand Devices [CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody]

• 04015630972241: 50 tests
• 04015630972234: 250 tests