MI Cancer Seek®

GUDID 00860008613325

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI) tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed as companion diagnostic indications are not prescriptive or conclusive for labeled use of any specific therapeutic product.

CARIS MPI, INC.

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00860008613325
• NIH Device Record Key: 9139e82b-a749-4cca-9a82-ec6ee03e7316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MI Cancer Seek®
• Version Model Number: MCS000
• Company DUNS: 009741254
• Company Name: CARIS MPI, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx
• Phone: 888-979-8669
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008613325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240010

FDA Product Code

• PQP: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

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: 2025-05-08
• Device Publish Date: 2025-04-30