Ortho 7% BSA (12 ML)


Product Overview

Ortho 7% BSA (12 ML)
ORTHO - 6986722


Device Description

A substance or reactant that is a bovine serum albumin (BSA) solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by reducing the zeta potential of red blood cells.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • -18.00
    • -18.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PPM

    Device Name: General Purpose Reagent

    Device Class: 1

    Physical State: N/A

    Definition: A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

    Submission Type ID: 4

    Review Panel: PA

    Review Code: N/A

    Technical Method: Y

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Diagnostic

    Regulation Number: 864.4010

    Third Party Flag: N

    Medical Specialty: PA


    Device Identifiers

    Device Id: 20758750030900

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10758750030903

    Package Quantity: 24

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 10758750030903

    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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