VENTANA antiHelicobacter pylori SP48 Rabbit Monoclonal Primary Antibody 06425623001

GUDID 04015630970018

250 Test

Ventana Medical Systems, Inc.

Helicobacter pylori antigen IVD, antibody

• Primary Device ID: 04015630970018
• NIH Device Record Key: aae49662-0a8c-41f5-8e71-313a6b29a9eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA antiHelicobacter pylori SP48 Rabbit Monoclonal Primary Antibody
• Version Model Number: 250 tests
• Catalog Number: 06425623001
• 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	04015630970018 [Primary]

FDA Product Code

• OWF: Immunohistochemical assay, Helicobacter pylori

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 [VENTANA antiHelicobacter pylori SP48 Rabbit Monoclonal Primary Antibody]

• 04015630970018: 250 Test
• 04015630970001: 50 test