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Creatinine Test System For At Home Prescription Use

FDA product code SHB · 1 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1225
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-01-21 – 2026-01-21

For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only.

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