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Dia Screen Reagent Strips

by Genesis Labs, Inc.

510(k) K952971

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952971 Date11 Aug 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JIL
Device Class
Class II
Regulation
21 CFR Part 862.1340
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Dia Screen Reagent Strips are a method, enzymatic, glucose (urinary, non-quantitative) device used in clinical chemistry for the detection of glucose in urine. The device is classified as a Class II medical device and has received FDA 510(k) clearance under K number K952971.

The strips are supplied by Genesis Labs, Inc. and are intended for use in clinical laboratory settings. They are non-sterile, single-use in vitro diagnostic reagents. No information regarding MRI safety, storage conditions, or specific sizes is provided in the data.

Other devices from Genesis Labs, Inc.

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Dia Screen Reagent Strip used for?

    The Dia Screen Reagent Strip is used for the detection of glucose in urine as a non-quantitative, enzymatic method in clinical chemistry settings, aiding in the assessment of urinary glucose levels.

  • Are Dia Screen Reagent Strips sterile or single-use?

    Dia Screen Reagent Strips are non-sterile and designed for single-use only, as specified in the device description, to prevent cross-contamination and ensure reliable in vitro diagnostic results.

  • Who manufactures the Dia Screen Reagent Strips and what is their FDA clearance number?

    The Dia Screen Reagent Strips are manufactured by Genesis Labs, Inc. and have received FDA 510(k) clearance under K number K952971, indicating substantial equivalence to a legally marketed predicate device.