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510(k) Data Aggregation

    K Number
    K162530
    Device Name
    Multichem IA Plus
    Manufacturer
    TECHNO-PATH MANUFACTURING
    Date Cleared
    2017-03-31

    (203 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNO-PATH MANUFACTURING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For In Vitro Diagnostic use only. Multichem IA Plus is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    The Multichem IA Plus control is prepared from human serum to which purified biochemical material (extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is used in liquid form for convenience. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the clinical range. Multichem IA Plus controls are prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is provided in liquid form for convenience. Each donor unit used in the preparation of the control material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV, and non-reactive for HBsAg.
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    K Number
    K132751
    Device Name
    MULTICHEM S PLUS / S PLUS (ASSAYED)
    Manufacturer
    TECHNO-PATH MANUFACTURING LTD.
    Date Cleared
    2013-10-22

    (49 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNO-PATH MANUFACTURING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multichem S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    The use of quality control material is indicated as an objective assessment of the precision of methods and techniques and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the analytical range. There is no difference in the formulation or manufacturing procedure between Multichem S Plus and Multichem S Plus (Assayed). Both are multi-analyte assayed QC materials with the same formula; however, there is a difference only in the product claims that are published to the users.
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    K Number
    K131993
    Device Name
    MULTICHEM U
    Manufacturer
    TECHNO-PATH MANUFACTURING LTD.
    Date Cleared
    2013-10-15

    (109 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNO-PATH MANUFACTURING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multichem U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level 1 and Level 2) are supplied in liquid form.
    Device Description
    Technopath has developed two levels of a urine control prepared from human urine to which purified biochemical material (extracts of human and animal origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. The two levels of control are available to allow performance monitoring within the analytical range. The following kit configurations are available: Model UC 201A.10 with Level 1 control; 15 vials with 10 mL contents Model UC 202A.10 with Level 2 control; 15 vials with 10 mL contents Model 05P80-10, with Bi-Level controls; 6 Level 1 vials and 6 Level 2 vials; vials have 5mL contents
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    K Number
    K131992
    Device Name
    MULTICHEM P
    Manufacturer
    TECHNO-PATH MANUFACTURING LTD.
    Date Cleared
    2013-09-25

    (89 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNO-PATH MANUFACTURING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multichem P is intended for use as a single level assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    The Multichem P control is prepared from human serum to which purified biochemical material (extracts of human origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. This control is provided in a single level control only with twelve vials, each vial containing 3 mL.
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    K Number
    K132091
    Device Name
    MULTICHEM IA AND IA PLUS
    Manufacturer
    TECHNO-PATH MANUFACTURING LTD.
    Date Cleared
    2013-09-20

    (74 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNO-PATH MANUFACTURING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multichem IA Plus is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    The Multichem IA Plus control is prepared from human serum to which purified biochemical material (extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is used in liquid form for convenience. Three levels of control are available to allow performance monitoring within the analytical range. Multichem IA Plus Level 1. Level 3 controls are available in tri-level and single level kit configurations. Individual analyte values listed in the package insert are specific for the instrument system utilized.
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    K Number
    K132174
    Device Name
    MULTICHEM WBT
    Manufacturer
    TECHNO-PATH MANUFACTURING LTD.
    Date Cleared
    2013-09-20

    (67 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNO-PATH MANUFACTURING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multichem WBT control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.
    Device Description
    Technopath has developed whole blood control materials prepared from human whole blood, to which whole blood purified biochemical material (extracts of human origin), chemicals, drugs, preservatives and stabilizers have been added. Three levels of control are available to allow performance monitoring within the analytical range.
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