SDK — Transdermal Test For Assessment Of Glomerular Filtration Rate Class III
FDA product code SDK covers "Transdermal Test For Assessment Of Glomerular Filtration Rate", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SDK
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- No
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.