BEUDAMED
    Product Code: QOF FDA class 2 21 CFR 866.3981

    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

    Microbiology

    The Multi-Target Respiratory Specimen Nucleic Acid Test Including SARS-CoV-2 and Other Microbial Agents is an in vitro diagnostic device intended to detect and identify SARS-CoV-2 and other microbial agents in human clinical respiratory specimens from patients suspected of respiratory infection, aiding in diagnosis in conjunction with clinical, epidemiologic, and laboratory data. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3981 in the Microbiology specialty. It carries product code QOF and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    33
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    18
    Years Active
    5

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    Basic Information

    Product Code
    QOF
    Device Class
    FDA class 2
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 33 510(k) clearances via K numbers.

    K Number Device Name
    K252932 Fast PCR Mini Respiratory Panel
    K252269 FINDER Flu A&B/SARS-CoV-2 Test
    K251742 VELO Respiratory Test
    K251978 LIAISON NES FLU A/B, RSV & COVID-19
    K252387 Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
    K250080 QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
    K243544 BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
    K243455 cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
    K250996 Xpert Xpress CoV-2/Flu/RSV plus
    K250995 Xpert Xpress CoV-2/Flu/RSV plus
    K243406 cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
    K243400 cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
    K242526 Visby Medical Respiratory Health Test
    K241573 Alinity m Resp-4-Plex
    K242071 Xpert Xpress CoV-2/Flu/RSV plus
    K241806 Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
    K241652 DASH® SARS-CoV-2 & Flu A/B Test
    K242465 Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
    K242353 QIAstat-Dx Respiratory Panel Mini
    K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
    K241194 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
    K233100 QIAstat-Dx® Respiratory Panel Plus
    K232954 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
    K231758 NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
    K233410 LIAISON PLEX Respiratory Flex Assay
    K231481 Xpert Xpress CoV-2/Flu/RSV plus
    K230956 BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System
    K223591 cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
    K222736 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
    K230719 BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
    K220963 Simplexa COVID-19 & Flu A/B Direct
    K213954 BIOFIRE SPOTFIRE Respiratory (R) Panel
    DEN200031 BioFire Respiratory Panel 2.1 (RP2.1)

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.