SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)
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)
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution
- 00884838064751 ()
712214
- Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost Compact
Not in Commercial Distribution
- 00884838064737 ()
712213
- Stationary basic diagnostic x-ray system, digital
SYRINGE LABELER
BECTON, DICKINSON AND COMPANY
516800
In Commercial Distribution
- 00382905168000 ()
516800
- Intravenous injection automated detection/documentation system processor/transmitter
ODXTT UG & ADF V10.0 USB - USA
LIFE TECHNOLOGIES CORPORATION
A51694
In Commercial Distribution
- 10190302017756 ()
- Human genomic analysis interpretive software
ODXTT UG & ADF V3.6 USB-US
LIFE TECHNOLOGIES CORPORATION
A49678
In Commercial Distribution
- 10190302015646 ()
- Human genomic analysis interpretive software
No Description
LIFE TECHNOLOGIES CORPORATION
A44913
In Commercial Distribution
- 10190302015134 ()
- Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A32441
In Commercial Distribution
- 10190302015103 ()
- Multiple tissue-associated protein/tumour marker IVD, reagent
No Description
LIFE TECHNOLOGIES CORPORATION
A38872
In Commercial Distribution
- 10190302014335 ()
- Nucleic acid hybridization detection IVD, control
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution
- 09357123000051 ()
MXU-RV71
- Mobile basic diagnostic x-ray system, digital