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Bordetella Pertussis Dna Assay System
FDA product code OZZ · Class 2 · Microbiology
27
Registered devices
0
Adverse events
2
Recalls
9
510(k) clearances
Devices with this code
Simplexa™ Bordetella Direct — DIASORIN MOLECULAR LLCcobas liat Bordetella panel control kit — Roche Molecular Systems, Inc.AmpliVue — QUIDEL CORPORATIONBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel — BIOFIRE DIAGNOSTICS, LLCQIAstat-Dx® Respiratory Panel — QIAGEN GmbHRespiratory Pathogens Flex (RP Flex) Amplification Tray — LUMINEX CORPORATIONFilmArray® Respiratory Panel (RP) — BIOFIRE DIAGNOSTICS, LLCSimplexa™ Bordetella Positive Control Pack — DIASORIN MOLECULAR LLCBordetella Direct Test — GREAT BASIN SCIENTIFIC, INC.Respiratory Pathogens Flex (RP Flex) Extraction Tray — LUMINEX CORPORATIONRespiratory Pathogens Flex (RP Flex) Amplification Tray — NANOSPHERE, INC.BioCode Respiratory Pathogen Panel — APPLIED BIOCODE, INC.Respiratory Pathogens Flex (RP Flex) Extraction Tray — NANOSPHERE, INC.Alethia™ Pertussis — MERIDIAN BIOSCIENCE, INC.cobas liat Bordetella panel nucleic acid test — Roche Molecular Systems, Inc.Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONRespiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge — NANOSPHERE, INC.BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel — BIOFIRE DIAGNOSTICS, LLCSolana — DIAGNOSTIC HYBRIDS, INC.FilmArray® Respiratory Panel (RP) — BIOFIRE DIAGNOSTICS, LLCARIES® Bordetella Assay — LUMINEX CORPORATIONFilmArray® Respiratory Panel 2 (RP2) — BIOFIRE DIAGNOSTICS, LLCillumigene Pertussis External Control Kit — MERIDIAN BIOSCIENCE, INC.Alethia™ Pertussis External Control Kit — MERIDIAN BIOSCIENCE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-24 | Ortho-Clinical Diagnostics, Inc. | It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (onl |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, re |
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