VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers

Product Overview

VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers
VITROS - 6905561

Device Description

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.

Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • -20.00
    • -20.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: PMT

    Device Name: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

    Device Class: 2

    Physical State: In vitro diagnostic device

    Definition: An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Immunoassay, ELISA

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Detection and determination the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma specimens.

    Regulation Number: 866.3215

    Third Party Flag: N

    Medical Specialty: MI

    Device Identifiers

    Device Id: 10758750032945

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

    Educational Resources