Transdermal Test For Assessment Of Glomerular Filtration Rate
SDK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SDK
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
GU
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A test used to assess a patients 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.