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Wunder Test

by Hien Helen Nguyen

510(k) K102428

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 NumberK102428 Date18 Apr 2012ClearedStatusActive

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  • Withdrawn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
LDJ
Device Class
Class II
Regulation
21 CFR Part 862.3870
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

The Wunder Test is an enzyme immunoassay device for the detection of cannabinoids in human bodily fluids. It is a pharmacological testing kit designed for clinical diagnostic purposes to identify drug metabolites present in samples.

The Wunder Test is supplied as a single-use device and is not indicated for MRI compatibility. It is authorized under FDA 510(k) clearance with product code LDJ and device class 2, approved for use in clinical toxicology settings. The device is stored according to manufacturer instructions and requires no special handling beyond standard laboratory protocols.

Questions

AI-generated answers, 28 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 Wunder Test used for?

    The Wunder Test is an enzyme immunoassay device designed for clinical diagnostic purposes to detect cannabinoids and their metabolites in human bodily fluids, commonly used in toxicology screening.

  • Is the Wunder Test a single-use device?

    Yes, the Wunder Test is supplied as a single-use device and is not indicated for MRI compatibility, requiring standard laboratory protocols for handling and storage.

  • What is the regulatory status of the Wunder Test?

    The Wunder Test is authorized under FDA 510(k) clearance with product code LDJ and device class 2, approved for use in clinical toxicology settings, with clearance number K102428.

  • How should the Wunder Test be stored?

    The Wunder Test should be stored according to manufacturer instructions and requires no special handling beyond standard laboratory protocols, ensuring proper environmental conditions for maintaining test integrity.