VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail 08507015001

GUDID 07613336160541

Ventana Medical Systems, Inc.

Kappa/lambda light chain messenger RNA IVD, probe

• Primary Device ID: 07613336160541
• NIH Device Record Key: 3b3141ce-ed35-4ba9-a5a4-97ef80123372
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail
• Version Model Number: 08507015001
• Catalog Number: 08507015001
• 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	07613336160541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN240025

FDA Product Code

• SDP: Kappa and Lambda immunoglobulin light chain in situ hybridization mRNA probe detection kit

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: 2025-02-28
• Device Publish Date: 2025-02-20

Devices Manufactured by Ventana Medical Systems, Inc.

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