VENTANA HE 600 Eosin 06544304001

GUDID 04015630974757

Ventana Medical Systems, Inc.

Biological stain IVD

• Primary Device ID: 04015630974757
• NIH Device Record Key: 35861757-c33f-4fba-8bef-3939ccc45764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA HE 600 Eosin
• Version Model Number: 06544304001
• Catalog Number: 06544304001
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630974757 [Primary]

FDA Product Code

• HYB: EOSIN Y

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: 2021-09-08
• Device Publish Date: 2021-08-31

Devices Manufactured by Ventana Medical Systems, Inc.

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• 04015630972197 - PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody: 2025-09-08
• 04015630971114 - LCS (Predilute): 2025-07-15
• 04015630976867 - ASSY,Reag.Disp.Card,PrepKit 18,BenchMark: 2025-07-15
• 04015630984299 - CINtec p16 Histology (50) CE: 2025-07-15
• 07613336100981 - ASSY,Reag.Disp.Card,PrepKit 13,BenchMark: 2025-07-15
• 07613336100998 - ASSY,Reag.Disp.Card,PrepKit 14,BenchMark: 2025-07-15