Sigma Diagnostics BUN Reagent

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K963537 ↗

FDA Product Code

LFP

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Diagnostics, Inc. →

• What is the Sigma Diagnostics BUN Reagent used for?

  The Sigma Diagnostics BUN Reagent is used in clinical chemistry for the measurement of blood urea nitrogen (BUN) via conductivity rate methodology. It is intended for in vitro diagnostic use in laboratory settings to assess kidney function and metabolic status.

• How is the Sigma Diagnostics BUN Reagent supplied and is it single-use?

  The reagent is supplied as either a liquid or lyophilized formulation for use with automated chemistry analyzers. It is a single-use reagent, meaning it is intended for one-time use per test and should not be reused to ensure accurate results and prevent contamination.

• What are the storage and handling requirements for the Sigma Diagnostics BUN Reagent?

  Storage conditions and handling should follow the manufacturer's labeling. The reagent is non-sterile and has not been evaluated for MRI safety. Proper storage as indicated on the label is necessary to maintain reagent stability and performance.