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Monitect Barbiturates Drug Screen Test

by Branan Medical Corporation

510(k) K002337

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 NumberK002337 Date22 Nov 2000ClearedStatusActive

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  • Withdrawn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)

Full name
Branan Medical Corporation Monitect Barbiturates Drug Screen Test
510(k) Number
FDA Product Code
DIS
Device Class
Class II
Regulation
21 CFR Part 862.3150
Advisory Committee
Clinical Toxicology
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.

The Monitect Barbiturates Drug Screen Test is an Enzyme Immunoassay, Barbiturate device used for drug screening. It is a type of clinical toxicology test.

The device is supplied by Branan Medical Corporation and has been found to be Substantially Equivalent. It has a product code of DIS and a regulation number of 862.3150. The device has an FDA 510(k) number of K002337 and is classified as a Class 2 device.

Other devices from Branan Medical Corp.

See all devices from Branan Medical Corp. →

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 Monitect Barbiturates Drug Screen Test used for?

    The Monitect Barbiturates Drug Screen Test is used for drug screening, specifically to detect barbiturates in clinical toxicology tests.

  • How is the device supplied?

    The device is supplied by Branan Medical Corporation.

  • What is the product code of the Monitect Barbiturates Drug Screen Test?

    The product code of the Monitect Barbiturates Drug Screen Test is DIS.

  • Is the Monitect Barbiturates Drug Screen Test a single-use or reusable device?

    The device description does not specify whether it is single-use or reusable, but it is classified as a Class 2 device.

  • What is the regulation number of the Monitect Barbiturates Drug Screen Test?

    The regulation number of the Monitect Barbiturates Drug Screen Test is 862.3150.