PIK3CA DNP Probe ASR 06621023001

GUDID 04015630970872

Ventana Medical Systems, Inc.

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD

• Primary Device ID: 04015630970872
• NIH Device Record Key: 02f7fce5-8d09-4d12-baa1-1be7f1619fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIK3CA DNP Probe ASR
• Version Model Number: 06621023001
• Catalog Number: 06621023001
• 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	04015630970872 [Primary]

FDA Product Code

• MVU: Reagents, specific, analyte

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