Sterichek Bicarb pH Reagent Strips

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K031267 ↗

FDA Product Code

MNV

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Sterichek Bicarb pH Reagent Strip used for?

  The Sterichek Bicarb pH Reagent Strip is used as a dialysate pH indicator to check the pH of bicarbonate solution used in preparing dialysate and concentrated bicarbonate solutions. It works by exposing the strip pad to a sample and comparing the resulting color to a provided color chart to determine pH levels.

• How are the Sterichek Bicarb pH Reagent Strips supplied and used?

  The strips are supplied as reagent test strips in a format designed for quick and convenient use. To use, the pad is exposed to a dialysate or bicarbonate solution sample, and the resulting color change is compared to a color chart to determine the pH value, enabling users to verify solution suitability for dialysis preparation.

• Are the Sterichek Bicarb pH Reagent Strips single-use or reusable?

  The Sterichek Bicarb pH Reagent Strips are intended for single-use only. Each strip is designed to be exposed to one sample, and the color change is read immediately after exposure. Reusing the strip could lead to inaccurate readings due to chemical saturation or contamination, so they should be discarded after one use.

• What regulatory authorization covers the Sterichek Bicarb pH Reagent Strips?

  The Sterichek Bicarb pH Reagent Strips are authorized under FDA 510(k) clearance K031267, which was granted on December 23, 2003. The device was found to be substantially equivalent to a predicate device and is classified as a Class II medical device under regulation number 876.5820 for dialysate pH indicators.