Ultra-Violet Bun Reagent Kit (Rate)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K871547 ↗

FDA Product Code

CDQ

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Glucose Enzyme - Color Reagent Set

  Class II

  FDA 510(k) K871650 Active Cleared 12 May 1987

• Creatine Kinase Mb Determination (UV)

  Class II

  FDA 510(k) K942958 Active Cleared 21 Nov 1994

• Colorimetric Bun Reagent Kit

  Class II

  FDA 510(k) K871651 Active Cleared 12 May 1987

• Ultra-Violet Glucose Reagent Kit

  Class II

  FDA 510(k) K871456 Active Cleared 29 Apr 1987

• Albumin Reagent Set

  Class II

  FDA 510(k) K905776 Active Cleared 26 Feb 1991

• Cholesterol Determination

  Class I

  FDA 510(k) K871260 Active Cleared 13 Apr 1987

See all devices from Biochemical Trade, Inc. →

• What clinical chemistry applications does this UV BUN reagent kit support, and how does it work?

  This kit is designed for measuring blood urea nitrogen (BUN) levels in clinical chemistry laboratories, which helps assess renal function and identify metabolic disorders. It uses ultraviolet (UV) spectrophotometry with urease and glutamic dehydrogenase reagents to quantify BUN, providing accurate results for diagnostic purposes.

• Is this reagent kit intended for single-use or repeated use, and what are the storage requirements?

  The kit is explicitly supplied as a single-use reagent set for laboratory use, requiring no additional sterilization beyond the manufacturer’s sealed packaging. Storage conditions and shelf life details are provided in the accompanying documentation, which must be followed to maintain accuracy and validity of the reagents.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  The device received FDA 510(k) clearance (K871547) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. This clearance confirms its compliance with FDA standards for in vitro diagnostic use in clinical chemistry, ensuring reliability for measuring BUN levels in accredited laboratories.

• Are there multiple sizes or models available for this reagent kit, or is it a standardized single configuration?

  The provided data does not specify multiple sizes or models—this appears to be a standardized single-use reagent kit for BUN measurement. If variations exist (e.g., reagent volumes or formats), they would be detailed in the manufacturer’s documentation or labeling, not in the regulatory filing.