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USDT Opiate Assay Column Catalog No. 9000-200

by U.S. Drug Testing, Inc.

510(k) K932318

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 NumberK932318 Date15 Jun 1993ClearedStatusActive

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  • Withdrawn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
DJG
Device Class
Class II
Regulation
21 CFR Part 862.3650
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 USDT Opiate Assay Column is a device intended to measure addictive narcotic pain-relieving opiate drugs in biological specimens including blood, serum, urine, gastric contents, and saliva. It is an enzyme immunoassay test system that uses antibody-based technology to screen for the presence of opiates.

This device is supplied as a single-use column and is classified as FDA Class 2. It is authorized under FDA 510K clearance with product code DJG and is intended for use in clinical toxicology, workplace drug testing, and emergency screening panels. The device is not MRI compatible and should be stored according to the manufacturer's instructions.

Other devices from U.S. Drug Testing, Inc.

Questions

AI-generated answers, 26 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 USDT Opiate Assay Column used for?

    This device is an enzyme immunoassay test system designed to screen for the presence of addictive narcotic pain-relieving opiate drugs in biological specimens such as blood, serum, urine, gastric contents, and saliva.

  • How is the device supplied and is it reusable?

    The device is supplied as a single-use column and is intended for one-time use. It is not designed for reuse.

  • What types of specimens can be tested with this device?

    The assay is intended to measure opiates in a variety of biological specimens, including blood, serum, urine, gastric contents, and saliva.

  • What is the regulatory status of this device?

    The USDT Opiate Assay Column is classified as a Class 2 medical device and is authorized under FDA 510K clearance with product code DJG.

  • How should the device be stored?

    The device should be stored according to the manufacturer's instructions to ensure proper performance.