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The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
Not in Commercial Distribution
- 10811877010569 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
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)
ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 1/2IN X 1IN, 7MM THICK
Integra Lifesciences Corporation
1690-ZZ
In Commercial Distribution
- 10381780000198 ()
- 00381780000191 ()
- M2691690ZZ0 ()
- 1.27 cm x 2.54 cm x 7.0 mm
- 1/2 in x 1in x 7.0 mm
1690-ZZ
- Collagen haemostatic agent, non-antimicrobial
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X200
In Commercial Distribution
- 00860008946478 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 200mm Covered Stent Graft Length
TSG-6.7X200
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X150
In Commercial Distribution
- 00860008946461 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 150mm Covered Stent Graft Length
TSG-6.7X150
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X100
In Commercial Distribution
- 00860008946454 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 100mm Covered Stent Graft Length
TSG-6.7X100
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X200
In Commercial Distribution
- 00860008946447 ()
- 6.0 mm Stent Graft Proximal Diameter
- 6.0 mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 6F Delivery System Outer Profile
- 200mm Covered Stent Graft Length
TSG-6.0X200
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X150
In Commercial Distribution
- 00860008946430 ()
- 6.0mm Stent Graft Proximal Diameter
- 6.0mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- Covered Stent Graft Length
TSG-6.0X150
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X100
In Commercial Distribution
- 00860008946423 ()
- 6.0 mm Stent Graft Proximal Diameter
- 6.0 mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 100 mm Covered Stent Graft Length
TSG-6.0X100
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-5.5X200
In Commercial Distribution
- 00860008946416 ()
- 5.5 mm Stent Graft Proximal Diameter
- 5.5 mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 200 mm Covered Stent Graft Length
TSG-5.5X200
- Central/peripheral venous endovascular stent-graft