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510(k) Data Aggregation

    K Number
    K990842
    Device Name
    SAS ROTA TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1999-08-09

    (147 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Why did this record match?
    Product Code :

    LIQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SASTM Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by rotavirus infection. This test is for professional use only.
    Device Description
    rapid, membrane-based immunogold assay
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    K Number
    K972895
    Device Name
    VIDAS ROTAVIRUS (RTV) ASSAY
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Date Cleared
    1997-10-03

    (59 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Why did this record match?
    Product Code :

    LIQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIDAS Rotavirus (RTV) Assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis.
    Device Description
    The VIDAS Rotavirus (RTV) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS (Vitek ImmunoDiagnositic Assay System) instrument. All assay steps and the assay temperature are controlled by the instrument. The VIDAS Rotavirus Assay contains a pipette tip-like disposable device, the Solid Phase Receptacle (SPR), a Reagent Strip, 1 Bottle of Standard, 1 Bottle of Positive Control, and 1 Bottle of Negative Control. The Kit contains a sufficient number of SPR's and Strips to perform 60 Tests. The SPR serves as the solid phase, as well as, the pipettor for the assay. The SPR is coated with rabbit anti-rotavirus antibodies. The Strip contains the reagents necessary to perform the assay, as well as, a sample well for placement of the specimen. Each RTV Assay requires one RTV Reagent Strip and one RTV SPR.
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    K Number
    K971585
    Device Name
    IMMUNOCARD STAT! ROTAVIRUS
    Manufacturer
    MERIDIAN DIAGNOSTICS, INC.
    Date Cleared
    1997-08-20

    (111 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Why did this record match?
    Product Code :

    LIQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis. For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.
    Device Description
    The ImmunoCard STAT! Rotavirus assay system is a membrane based immunogold assay for rotavirus. Each kit contains the following components: ImmunoCard STAT! Rotavirus devices(30), Positive Control (1.8ml), Sample Diluent (10.5ml), Transfer Pipets (30). In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.
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    K Number
    K964424
    Device Name
    ROTAVIRUS EIA
    Manufacturer
    TRINITY BIOTECH, INC.
    Date Cleared
    1997-08-08

    (276 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Why did this record match?
    Product Code :

    LIQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants. The performance characteristic was not determined in the elderly population.
    Device Description
    Not Found
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    K Number
    K965092
    Device Name
    VIDAS ROTAVIRUS ASSAY
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Date Cleared
    1997-05-05

    (137 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Why did this record match?
    Product Code :

    LIQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.
    Device Description
    The VIDAS RTV Assay detects the presence of rotavirus antigen in stool specimens. Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.
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    K Number
    K951208
    Device Name
    ROTA-DAN RAPID ROTAVIRUS EIA KIT
    Manufacturer
    ELDAN TECHNOLOGIES, LTD.
    Date Cleared
    1996-02-14

    (334 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Why did this record match?
    Product Code :

    LIQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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