202 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
QUIDEL MOLECULAR RSV + HMPV ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
FDA 510(k)
FDA Class 2
·Microbiology
ID NOW Influenza A & B 2
FDA 510(k)
FDA Class 2
·Microbiology
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
FDA 510(k)
FDA Class 2
·Microbiology
Idylla Respiratory (IFV-RSV) Panel
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Respiratory Panel (RP) for use with FilmArray Torch
FDA 510(k)
FDA Class 2
·Microbiology
FILMARRAY RP PANEL
FDA 510(k)
FDA Class 2
·Microbiology
PRODESSE PROADENO
FDA 510(k)
FDA Class 2
·Microbiology
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
FDA 510(k)
FDA Class 2
·Microbiology
Solana Influenza A+B Assay
FDA 510(k)
FDA Class 2
·Microbiology
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
FDA 510(k)
FDA Class 2
·Microbiology
FILMARRAY RESPIRATORY PANEL (RP)
FDA 510(k)
FDA Class 2
·Microbiology
PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
PROADENO+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ID-TAG RESPIRATORY VIRAL PANEL
FDA 510(k)
FDA Class 2
·Microbiology
FILMARRAY RESPIRATORY PANEL (RP)
FDA 510(k)
FDA Class 2
·Microbiology