Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

FDA product code NTZ · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5820
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-06-13 – 2005-06-13

Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.

↑