Urine Opiates (OPI) Screen Flex Reagent Cartridge, Catalog No. DF 90A

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K000464 ↗

FDA Product Code

DJG

Device Class

Class II

Regulation

21 CFR Part 862.3650

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Dade Behring, Inc. →

• What is the primary purpose of the Urine Opiates Screen Flex Reagent Cartridge?

  This device is designed for use in clinical toxicology settings to perform qualitative or quantitative detection of opiate drugs and their metabolites in human urine specimens.

• How is this device supplied for clinical use?

  The device is supplied as a reagent cartridge, catalog number DF 90A, specifically engineered for integration into clinical toxicology testing systems.

• What is the regulatory status of this reagent cartridge?

  The device is regulated under 21 CFR 862.3650 and has received FDA 510(k) clearance for its intended use in clinical toxicology.