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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.
MCS000
In Commercial Distribution
- 00860008613325 ()
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Sterilization Tray
Lumicell, Inc.
900-00209
In Commercial Distribution
- 00860008537898 ()
- Device sterilization/disinfection container, reusable
eCoin External Controller Kit
Valencia Technologies Corporation
1011-5436
In Commercial Distribution
- 00860007896972 ()
1011-5436
- Tibial nerve implantable incontinence-control electrical stimulation system
eCoin Patient Kit
Valencia Technologies Corporation
1011-1901
In Commercial Distribution
- 00860007896965 ()
- Tibial nerve implantable incontinence-control electrical stimulation system
eCoin External Controller Kit
Valencia Technologies Corporation
1011-1752
In Commercial Distribution
- 00860007896910 ()
- Tibial nerve implantable incontinence-control electrical stimulation system
eCoin Device Kit
Valencia Technologies Corporation
1011-2447
In Commercial Distribution
- 00860007896903 ()
1011-2447
- Tibial nerve implantable incontinence-control electrical stimulation system
Calibration Plate, Disposable
Lumicell, Inc.
810-00214
In Commercial Distribution
- 00860008537829 ()
- 10860003252564 ()
- 00860003252567 ()
- Intraoperative tumour margin fluorescence imaging system probe calibrator
Handheld Probe
Lumicell, Inc.
810-00211
In Commercial Distribution
- 00860003252550 ()
- 00860003252581 ()
- Length: 1.28 Inch
810-00211
- Intraoperative tumour margin fluorescence imaging system probe
Workstation Assembly
Lumicell, Inc.
810-00217
In Commercial Distribution
- 00860003252543 ()
- 00860008537805 ()
- Intraoperative tumour margin fluorescence imaging system
Light source
Lumicell, Inc.
810-00212
In Commercial Distribution
- 00860003252598 ()
- 00860003252536 ()
- Intraoperative tumour margin fluorescence imaging system