HybReady Solution 05917557001

GUDID 04015630971060

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 04015630971060
• NIH Device Record Key: 8b07099a-6830-4657-aa1a-19f3782eeb23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HybReady Solution
• Version Model Number: 05917557001
• Catalog Number: 05917557001
• 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	04015630971060 [Primary]

FDA Product Code

• PPM: General purpose reagent

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

Devices Manufactured by Ventana Medical Systems, Inc.

• 07613336221099 - VENTANA FGFR2b (FPR2-D) Mouse Monoclonal Antibody: 2024-02-07
• 07613336219898 - anti-CD8 (SP239) Rabbit Monoclonal Primary Antibody: 2023-07-07
• 04015630967087 - CONFIRM anti-S100 (Polyclonal) Primary Antibody: 2022-12-15
• 04015630970063 - CONFIRM anti-ALK1 (ALK01) Primary Antibody: 2022-12-15
• 04015630970445 - CINtec® p16 Histology: 2022-12-15
• 04015630971015 - Anti-p53 (Bp53-11) Primary Antibody: 2022-12-15
• 04015630971053 - CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody: 2022-12-15
• 04015630971183 - CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody: 2022-12-15