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Bun Reagent Astra 4 & 8 Analyzers

by Nobel Scientific Industries, Inc.

510(k) K802518

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802518 Date12 Nov 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CDN
Device Class
Class II
Regulation
21 CFR Part 862.1770
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a urease-based photometric reagent for measuring blood urea nitrogen (BUN) levels, classified under clinical chemistry diagnostics. It employs enzymatic hydrolysis of urea to ammonia, which is then photometrically quantified to determine serum or plasma urea nitrogen concentrations, aiding in the assessment of renal function and metabolic disorders.

The BUN reagent is supplied as a liquid for use with the Astra 4 and Astra 8 automated clinical chemistry analyzers. It is intended for single-use in a laboratory setting and requires no sterilization beyond standard reagent handling procedures. The device is regulated under FDA 510(k) clearance (K802518) and falls under product code CDN, with a classification of Class II. Storage conditions and expiration are not specified in the provided data.

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