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Urea Nitrogen (BUN) Liqui-UV

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962418

by Stanbio Laboratory

Identifiers

510(k) Number
K962418 FDA 510(k)
FDA Product Code
CDQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1770 FDA 510(k)
Regulation Number
862.1770 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Urea Nitrogen (BUN) Liqui-UV is a clinical chemistry reagent test for the quantitative determination of urea nitrogen in blood or serum. It uses a modified urease and glutamic dehydrogenase enzymatic method with colorimetric detection at 340 nm.

The test is supplied as ready-to-use liquid reagents, including R1 (4 x 30 mL), R2 (4 x 5 mL), and a standard (1 x 3 mL at 30 mg/dL). The working reagent is stable for up to 4 weeks when stored at 2–8°C, and the assay is linear to 140 mg/dL BUN. It is intended for use in clinical laboratories and has received FDA 510(k) clearance under product code CDQ and regulation number 862.1770.

Frequently asked questions

What is Urea Nitrogen (BUN) Liqui-UV used for?

Urea Nitrogen (BUN) Liqui-UV is used for the quantitative determination of urea nitrogen in blood or serum samples. It employs a modified urease and glutamic dehydrogenase enzymatic method with colorimetric detection at 340 nm to measure BUN levels, which helps assess kidney function and metabolic status in clinical laboratory settings.

How is Urea Nitrogen (BUN) Liqui-UV supplied and what are its components?

The test is supplied as ready-to-use liquid reagents, consisting of R1 (4 bottles of 30 mL each), R2 (4 bottles of 5 mL each), and a single standard (1 bottle of 3 mL at 30 mg/dL BUN concentration). This format allows for immediate use in clinical chemistry analyzers without additional preparation.

What is the stability and storage requirement for Urea Nitrogen (BUN) Liqui-UV reagents?

The working reagent is stable for up to 4 weeks when stored at 2–8°C. Proper refrigeration is essential to maintain reagent integrity and ensure accurate test results over the stated stability period. The reagents should not be frozen or exposed to temperatures outside this range.

What is the measurement range and linearity of the Urea Nitrogen (BUN) Liqui-UV assay?

The assay is linear up to 140 mg/dL BUN, allowing accurate quantification of urea nitrogen within this range. This makes it suitable for routine clinical testing where BUN levels typically fall, with results traceable to the provided 30 mg/dL standard for calibration.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Liqui-UV Urea Nitrogen (BUN) Rate Test - Medline, Stanbio Urea Nitrogen (BUN) Liqui-UV Test (RATE), 4 x 30 mL, Stanbio™ BUN Liquid Reagent for Diagnostic Set - Fisher Sci, Stanbio Laboratory Reagent Kit Liqui-UV® Renal / General Chemistry Urea ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stanbio Laboratory

Sources (1)

  • FDA 510(k) K962418 24 fields · synced Oct 1, 2026