VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack

Product Overview

VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack
VITROS - 6197735

Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using a chemiluminescent immunoassay method.

Environmental Conditions

  • Special Storage Condition, Specify
    • Do not freeze
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • 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: 10758750033287

    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