← Back to catalogue

Urea Nitrogen (BUN) Liquid Reagent

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981106

by Teco Diagnostics

Identifiers

510(k) Number
K981106 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)

The Urea Nitrogen (BUN) Liquid Reagent is a diagnostic liquid reagent used for the colorimetric determination of urea nitrogen in human serum or plasma. It employs enzymatic reactions involving urease and glutamic dehydrogenase to quantify BUN levels, supporting clinical chemistry assessments. This reagent is designed for routine laboratory testing to monitor renal function and evaluate therapeutic responses.

Supplied as a liquid reagent set, the product includes vials of BUN enzyme reagent, color developer, and a standard for calibration. It is intended for single-use in clinical laboratory settings and requires no special sterility beyond standard aseptic handling. The reagent is classified under FDA 510(k) clearance (K981106) and adheres to regulatory standards for clinical chemistry diagnostics, ensuring compliance with medical device regulations. Storage conditions and exact vial sizes are specified in the accompanying documentation.

Frequently asked questions

What is the Urea Nitrogen (BUN) Liquid Reagent used for?

The Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent is designed for the colorimetric measurement of urea nitrogen in human serum or plasma. It employs enzymatic reactions involving urease and glutamic dehydrogenase to quantify BUN levels, which helps clinicians assess renal function and evaluate therapeutic responses in routine laboratory settings.

How is the BUN Liquid Reagent supplied, and what does the set include?

The reagent is supplied as a liquid reagent set, containing vials of BUN enzyme reagent, color developer, and a standard for calibration. This setup ensures compatibility for accurate BUN testing in clinical chemistry laboratories. The exact vial sizes and storage instructions are detailed in the accompanying documentation.

Is the BUN Liquid Reagent sterile, and how should it be handled?

The reagent does not require special sterility beyond standard aseptic handling, as it is intended for single-use in clinical laboratory settings. Proper laboratory practices, such as avoiding contamination and adhering to manufacturer guidelines, ensure reliable results and compliance with regulatory standards.

Is this reagent intended for single-use or reuse?

The Urea Nitrogen (BUN) Liquid Reagent is explicitly designed for single-use only. This prevents cross-contamination and ensures consistent, accurate test results in clinical chemistry workflows. Reuse is not recommended or supported by the manufacturer.

What regulatory clearance does this BUN reagent hold?

The Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent holds FDA 510(k) clearance under the classification of Clinical Chemistry, with a clearance number of K981106. This indicates it is deemed substantially equivalent to a predicate device and complies with U.S. medical device regulations for clinical chemistry diagnostics.

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: B551-132, Teco Diagnostics BUN REAGENT SET | Buy Online - Fisher Sci, TECO DIAGNOSTICS UREA NITROGEN (BUN) LIQUID REAGENT - doczz.net, Teco Diagnostics BUN REAGENT SET | Buy Online - Fisher Sci

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA 510(k) K981106 24 fields · synced Oct 1, 2026