Product code SDK

Device name
Transdermal Test For Assessment Of Glomerular Filtration Rate
Medical specialty
Unknown
Device class
3
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A test used to assess a patient’s glomerular filtration rate (GFR) by injecting a fluorescent tracer molecule into the blood stream and measuring the amount of fluorescence through the skin with a transdermal sensor.
Source
FDA openFDA device classification dataset

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