Quantitation of Organophosphate Metabolites in Urine by Lc/Ms/Ms

No FDA recalls found in the data synced 10 Oct 2026.

De Novo Number

DEN130005 ↗

FDA Product Code

PDY

Device Class

Class II

Regulation

21 CFR Part 862.3652

Advisory Committee

Clinical Toxicology

FDA Decision

DENG De Novo granted

• B. anthracis Real-time PCR Assay

  Class II

  FDA 510(k) K262368 Active Cleared 7 Oct 2026

• CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit

  Class II

  FDA 510(k) K263035 Active Cleared 30 Sep 2026

• Rickettsia Real-time PCR Assay

  Class II

  FDA 510(k) K170940 Active Cleared 29 Jun 2017

• Sera for Antinuclear Antibodies

  Class II

  FDA 510(k) K820945 Active Cleared 26 Oct 1982

• Anthracis Real-Time Pcr Assay

  Class II

  FDA 510(k) K140426 Active Cleared 22 May 2014

• CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

  Class II

  FDA 510(k) K190302 Active Cleared 27 Mar 2019

See all devices from Centers for Disease Control and Prevention →