Home › Device types › OZX
Mycoplasma Pneumoniae Dna Assay System
FDA product code OZX · Class 2 · Microbiology
19
Registered devices
0
Adverse events
0
Recalls
3
510(k) clearances
Devices with this code
BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel — BIOFIRE DIAGNOSTICS, LLCQIAstat-Dx® Respiratory Panel — QIAGEN GmbHFilmArray® Respiratory Panel (RP) — BIOFIRE DIAGNOSTICS, LLCePlex System — GENMARK DIAGNOSTICS, INC.illumigene Mycoplasma Direct — MERIDIAN BIOSCIENCE, INC.BioCode Respiratory Pathogen Panel — APPLIED BIOCODE, INC.illumigene Mycoplasma Direct External Control Kit — MERIDIAN BIOSCIENCE, INC.ePlex System — GENMARK DIAGNOSTICS, INC.ePlex System — GENMARK DIAGNOSTICS, INC.NxTAG® Respiratory Pathogen Panel — Luminex Molecular Diagnostics, IncAlethia™ Mycoplasma Direct External Control Kit — MERIDIAN BIOSCIENCE, INC.BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel — BIOFIRE DIAGNOSTICS, LLCFilmArray® Respiratory Panel (RP) — BIOFIRE DIAGNOSTICS, LLCFilmArray® Respiratory Panel 2 (RP2) — BIOFIRE DIAGNOSTICS, LLCillumigene Mycoplasma — MERIDIAN BIOSCIENCE, INC.Alethia™ Mycoplasma Direct — MERIDIAN BIOSCIENCE, INC.FilmArray® Respiratory Panel (RP) EZ — BIOFIRE DIAGNOSTICS, LLCFilmArray® Respiratory Panel 2 (RP2) — BIOFIRE DIAGNOSTICS, LLCillumigene Mycoplasma External Control Kit — MERIDIAN BIOSCIENCE, INC.
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.