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No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution
- 03607450867657 ()
86765
- Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution
- 03607450000047 ()
86765
- Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution
- 03607450000030 ()
87111
- Laboratory instrument/analyser application software IVD
Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution
- 01812125010081 ()
CP3511
- Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine ANCA Classifier
In Commercial Distribution
- 08059304340239 ()
- Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine DNA Classifier
In Commercial Distribution
- 08059304340222 ()
- Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine ANA HEp-2 Classifier
In Commercial Distribution
- 08059304340215 ()
- Laboratory instrument/analyser application software IVD
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution
- 10385083000565 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution
- 20385083000531 ()
- 10385083000527 ()
- 20385083000579 ()
- 20385083000753 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution
- 10385083000503 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution
- 10385083000336 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-BLE-H1-520
In Commercial Distribution
- 10385083000213 ()
- 10385083000114 ()
- 10385083000138 ()
- 20385083000210 ()
- 20385083000135 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller (PDM) mg/dl - English with PodPals
Insulet Corporation
PDM-H001-G-XX
In Commercial Distribution
- 10385083000022 ()
- 30385083000019 ()
- 30385083000095 ()
SKT-H001-G-X9
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution
- 10385081120302 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.
CliniSys, Inc
6.3
Not in Commercial Distribution
- B236SMG6300 ()
- Human genomic analysis interpretive software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.75.20171019
In Commercial Distribution
- B133NEUROQ1 ()
- Neurosurgical ultrasound navigation system application software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.6.20131127
In Commercial Distribution
- B133NEUROQ0 ()
- Neurosurgical ultrasound navigation system application software
No Description
Roche Molecular Systems, Inc.
08403864001
Not in Commercial Distribution
- 07613336156551 ()
08403864001
- Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08403856001
In Commercial Distribution
- 07613336156544 ()
08403856001
- Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08302375001
Not in Commercial Distribution
- 07613336150047 ()
08302375001
- Laboratory instrument/analyser application software IVD