HIV RNA 3.0 Assay (bDNA) US IVD (Box 2)


Product Overview

HIV RNA 3.0 Assay (bDNA) US IVD (Box 2)
VERSANT® HIV-1 RNA 3.0 Assay bDNA - 10335367


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • -60.00
    • -80.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MZF

    Device Name: Test, Hiv Detection

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: MI

    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: 866.3956

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00630414457611

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos