Methadone Metabolite Eia Assay

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

510(k) Number

K931780 ↗

FDA Product Code

DJR

Device Class

Class II

Regulation

21 CFR Part 862.3620

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• T4 Diagnostic Kit

  Class II

  FDA 510(k) K820251 Active Cleared 5 May 1982

• Serum Tox Calibrator

  Class II

  FDA 510(k) K961372 Active Cleared 1 May 1996

• Methadone Enzyme Immunoassay

  Class II

  FDA 510(k) K934667 Active Cleared 26 Jan 1994

• Cannabinoid Urine Controls

  Class I

  FDA 510(k) K932113 Active Cleared 29 Jun 1993

• Amphetamines Eia Assay Modification

  Class II

  FDA 510(k) K934891 Active Cleared 13 Jan 1994

• Thc Urine Calibrators

  Class II

  FDA 510(k) K923386 Active Cleared 14 Sep 1992

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• What is the Methadone Metabolite EIA Assay used for?

  The Methadone Metabolite EIA Assay is used for the qualitative and semi-quantitative detection of methadone metabolite in human urine samples, primarily in laboratory settings within the medical specialty of Clinical Toxicology.

• Is the Methadone Metabolite EIA Assay supplied with any regulatory authorizations?

  Yes, the Methadone Metabolite EIA Assay is supplied with an FDA 510K authorization, indicating its regulation under the specified number 862.3620.

• What technology does the Methadone Metabolite EIA Assay utilize?

  The Methadone Metabolite EIA Assay utilizes enzyme immunoassay technology to identify the presence of methadone metabolite in human urine samples.

• What is the product code for the Methadone Metabolite EIA Assay?

  The product code for the Methadone Metabolite EIA Assay is DJR.