VENTANA FOLR1 (FOLR1-2.1) RxDx Assay 07727917001

GUDID 07613336103241

Ventana Medical Systems, Inc.

Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody Folate receptor alpha (FRa) IVD, antibody

• Primary Device ID: 07613336103241
• NIH Device Record Key: db3020ae-e09b-476e-afa8-3cfcdf64b555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
• Version Model Number: 07727917001
• Catalog Number: 07727917001
• 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	07613336103241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220006

FDA Product Code

• QUL: Immunohistochemistry Assay, Antibody, FOLR1

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: 2022-12-09
• Device Publish Date: 2022-12-01

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