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Enzyme Immunoassay, Cortisol, Salivary

FDA product code NHG · Class 2 · Clinical Chemistry

24
Registered devices
20
Adverse events
5
Recalls
7
510(k) clearances

Devices with this code

Pantex — PantexPantex P631SC — PantexElecsys Cortisol Test System — Roche Diagnostics GmbHPantex P631SC — PantexSalimetrics — SALIMETRICS, LLCPantex P631SC — PantexCortisol Saliva Luminescence Immunoassay — IBL International GmbHPantex P631SC — PantexPantex P631SC — PantexPantex P631SC — PantexCortisol Saliva Luminescence Immunoassay — IBL International GmbHPantex — PantexPantex P631SC — PantexPantex Universal — PantexSalimetrics — SALIMETRICS, LLCPantex P631SC — PantexSalimetrics — SALIMETRICS, LLCPantex P631SC — PantexPantex P631SC — PantexSalivary Cortisol ELISA — IBL AmericaPantex P631SC — PantexPantex P631SC — PantexPantex P631SC — PantexPantex P631SC — Pantex

Recent recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2018-01-12Tecan US, Inc.Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comp
2007-05-15Roche Diagnostics Corp.The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.