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System, Breath Measurement

FDA product code NRH · Class 1 · Clinical Chemistry

26
Registered devices
0
Adverse events
3
Recalls
4
510(k) clearances

Devices with this code

BreathTracker — QUINTRON INSTRUMENT COMPANY, INC.Pure Comfort Breath Exerciser — HOME AIDE DIAGNOSTICS, INC.Extraction System Output Tubing — QUINTRON INSTRUMENT COMPANY, INC.FILTER, FOAM PLUG, 10 PACK — QUINTRON INSTRUMENT COMPANY, INC.Gastrolyzer — BEDFONT SCIENTIFIC LIMITEDSX2 Plus Maintenance Kit — QUINTRON INSTRUMENT COMPANY, INC.Screwdriver, Valve Removal Tool — QUINTRON INSTRUMENT COMPANY, INC.Drying Tube End, Sample Inlet, Male — QUINTRON INSTRUMENT COMPANY, INC.BreathTracker — QUINTRON INSTRUMENT COMPANY, INC.Drying Tube End, Sample Inlet, Female — QUINTRON INSTRUMENT COMPANY, INC.Tank Support, Safety, Table-Top Plastic — QUINTRON INSTRUMENT COMPANY, INC.EXTRACTOR REPAIR — QUINTRON INSTRUMENT COMPANY, INC.VIAL ADAPTER, PLASTIC, 5 PACK — QUINTRON INSTRUMENT COMPANY, INC.SivRite-4 Tubing Assembly — QUINTRON INSTRUMENT COMPANY, INC.Gastrolyzer — BEDFONT SCIENTIFIC LIMITEDLOANER ALVEOVAC EXTRACTOR — QUINTRON INSTRUMENT COMPANY, INC.SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USP — QUINTRON INSTRUMENT COMPANY, INC.AlveoVac Exraction System-USA 24VDC — QUINTRON INSTRUMENT COMPANY, INC.BT UPGRADE, CUI, INC POWER SUPPLIES — QUINTRON INSTRUMENT COMPANY, INC.BREATHTRACKER SERIES REPAIR — QUINTRON INSTRUMENT COMPANY, INC.BT GC LOANER SC — QUINTRON INSTRUMENT COMPANY, INC.BreathPrep Desiccant — QUINTRON INSTRUMENT COMPANY, INC.DUST BARRIER, 5 PACK — QUINTRON INSTRUMENT COMPANY, INC.Patient Sample Drying Tube — QUINTRON INSTRUMENT COMPANY, INC.

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.

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