BEUDAMED
    Product Code: PMN FDA class 2 21 CFR 866.3920

    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

    Microbiology

    The Assayed External Control Material For Microbiology Nucleic Acid Amplification (NAT) Assays (product code PMN) is a Class 2 microbiology device consisting of assayed external quality control material used to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use, regulated under 866.3920. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    31
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    8
    Years Active
    10

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    Basic Information

    Product Code
    PMN
    Device Class
    FDA class 2
    Regulation Number
    866.3920
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 31 510(k) clearances via K numbers.

    K Number Device Name
    K260577 FilmArray TF Control Panel M527
    K260041 MDx-Chex for BCP
    K254166 MDx-Chex for BCN
    K254167 MDx-Chex for BCY
    K251526 FilmArray GI Control Panel M238
    K241289 SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
    K233611 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
    K231223 MDx-Chex for BC-GN
    K231221 MDx-Chex for BC-GP
    K230868 SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
    K221253 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
    K203680 BioFire JI Control Panel M420
    K201403 NATtrol BD MAX Vaginal Panel External Controls
    K212576 MDx-Chex for BCID2
    K202196 BioFire RP2.1/RP2.1plus Control Panel M441
    K202382 FilmArray Global Fever Panel External Control Kit
    K200010 FilmArray BCID2 Control Panel M416
    K190086 Cepheid Xpert Respiratory Control Panel
    K191168 Cepheid Xpert SA Nasal Complete Control Panel
    K191172 Cepheid Xpert MRSA NxG Control Panel
    K190223 Cepheid Xpert CT/NG Control Panel
    K190222 FilmArray Pneumonia/Pneumoniaplus Control
    K190463 Cepheid Xpert C. difficile/Epi Control Panel
    K182472 Cepheid Xpert GBS LB Control Panel
    K181683 BD MAX CT/GC/TV 20-Day QC Panel
    K181711 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
    K173171 FilmArray RP2/RP2plus Control Panel
    K163522 FilmArray Warrior Control Panel M290
    K161573 FilmArray RP EZ Control Panel M265
    K152679 Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
    DEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.