VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary

GUDID 07613336100592

For use the MMR IHC Panel

Ventana Medical Systems, Inc.

Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent

• Primary Device ID: 07613336100592
• NIH Device Record Key: afa222e8-08eb-405d-968b-14645549e953
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary
• Version Model Number: 790-5094
• 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: true
• 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	07613336100592 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170030

FDA Product Code

• PZJ: Lynch Syndrome Test System
• QNH: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-08

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