VENTANA HA Dx Assay 08289018001

GUDID 07613336149829

Ventana Medical Systems, Inc.

Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent Hyaluronic acid (HA) IVD, reagent

• Primary Device ID: 07613336149829
• NIH Device Record Key: 03c5375c-bc26-48aa-ab9d-9a0150107cad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA HA Dx Assay
• Version Model Number: 08289018001
• Catalog Number: 08289018001
• 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	07613336149829 [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: 2021-02-11
• Device Publish Date: 2021-02-03

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