The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum.


Product Overview

The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intact
PTH (Parathyroid) Intact ELISA - EIA-3645


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen, using an enzyme immunoassay (EIA) method.


Environmental Conditions

No Data Available


Device Sizes

  • Sample Diluent
  • Reconstitution Solution
  • TMB Substrate
  • Stop Solution
  • Controls 1 & 2
  • Calibrators
  • Biotinylated Antibody Solution
  • Enzyme Antibody Solution
  • Wash Concentrate
  • Total Volume: 7 Milliliter
  • Total Volume: 2 Milliliter
  • Total Volume: 5 Milliliter
  • Total Volume: 30 Milliliter
  • Total Volume: 0.5 Milliliter
  • Total Volume: 20 Milliliter
    • Sample Diluent
    • Reconstitution Solution
    • TMB Substrate
    • Stop Solution
    • Controls 1 & 2
    • Calibrators
    • Biotinylated Antibody Solution
    • Enzyme Antibody Solution
    • Wash Concentrate
    • Total Volume: 7 Milliliter
    • Total Volume: 2 Milliliter
    • Total Volume: 5 Milliliter
    • Total Volume: 30 Milliliter
    • Total Volume: 0.5 Milliliter
    • Total Volume: 20 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CEW

    Device Name: Radioimmunoassay, Parathyroid Hormone

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.1545

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00840239036452

    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


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