BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DeepChek® Assay INTEGRASE Genotyping and Drug Resistance

    Reg #: 3016903806 · FEI: 3016903806 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    76
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AdvancedDx Biological Laboratories USA Inc
    Registration Number
    3016903806
    FEI Number
    3016903806
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-7 Perry Way, Unit 15
    City
    Newburyport
    State
    MA
    ZIP
    01950
    Country
    US

    Owner / Operator

    Firm Name
    Advanced Biological Laboratories S.A.
    Operator Number
    10046715
    Address
    52-54 Avenue du X Septembre
    City
    Luxembourg
    State
    Grevenmacher
    Postal Code
    2550
    Country
    LU
    Correspondent
    Chalom B Sayada

    Products

    Device Name Product Code
    Research Use Only/Microbiology OTT

    Proprietary Names

    DeepChek® Assay INTEGRASE Genotyping and Drug Resistance DeepChek® Assay 16S rRNA Bacterial identification UltraGene Assay Respiratory pathogens 21 plus UltraGene Assay Respiratory pathogens 34 UltraGene Assay Stool parasites UltraGene Assay Respiratory pathogens 21 UltraGene Assay HCoV UltraGene Assay STD9 DeepChek® Assay NS5A (GT2) Drug Resistance UltraGene Assay Fever and rash UltraGene Assay Eye UltraGene Assay Atypical CAP UltraGene Assay Respiratory pathogens 22 UltraGene Assay Dermatophytes DeepChek Assay Whole Genome RSV Genotyping DeepChek® Assay NS5A Genotyping and Drug Resistance DeepChek® Assay HPV messenger RNA Genotyping DeepChek® Assay GP41/GP120 Genotyping and Drug Resistance UltraGene Assay Viral meningitis DeepChek® Assay NS5B Genotyping and Drug Resistance UltraGene Assay Genital ulcer DeepChek® Assay RT Genotyping and Drug Resistance DeepChek® Assay GAG Genotyping and Drug Resistance DeepChek® NGS LIBRARY PREPARATION (MGI) UltraGene Assay FLU DeepChek® NGS LIBRARY PREPARATION UltraGene Assay Bacterial pneumonia CAP DeepChek® Assay V3 LOOP / TROPISM UltraGene Assay Zika/Dengue/Chik UltraGene Assay MERS-CoV DeepChek® UDI ADAPTERS UltraGene Assay Measles DeepChek® Assay Whole Genome HBV Genotyping DeepChek® SANGER SEQUENCING REACTION UltraGene Assay Bacterial meningitis UltraGene Assay Vesicular rash DeepChek® Assay HIV-1 Full PR/RT/INT Drug Resistance DeepChek® Assay 13-Plex KB Drug Susceptibility Testing UltraGene Assay Viral meningitis plus DeepChek® Assay REVERSE TRANSCRIPTASE SIMPLEX Genotyping and Drug Resistance DeepChek®Assay Whole Genome HDV Genotyping DeepChek® Assay NS3 Genotyping and Drug Resistance UltraGene Assay Neuro9 DeepChek® UDI ADAPTERS (MGI) UltraGene Assay Respiratory pathogens 33 UltraGene Assay Urethritis plus UltraGene Assay BKV DeepChek® Assay HPV Genotyping DeepChek® Assay Whole Genome HIV-1 Genotyping UltraGene Assay Dengue / Chik UltraGene Assay Tropical fever core DeepChek® Assay 18S rRNA Fungi Identification UltraGene Assay Hepatitis E RNA UltraGene Assay EPA DeepChek® Assay CORE Genotyping UltraGene Assay FLU / HRSV DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Genotyping and Drug Resistance DeepChek® Assay Whole Genome BKV Genotyping UltraGene Assay Viral gastroenteritis DeepChek® Assay Whole Genome Influenza A/B Genotyping UltraGene Assay Pneumocystis jirovecii UltraGene Assay Urethritis basic DeepChek® Assay UL54 / UL56 / UL97 Drug Resistance DeepChek® Assay NS5B (BACK-UP) Genotyping UltraGene Assay Malaria differentiation DeepChek® ADAPTERS UltraGene Assay Flu differentiation UltraGene Assay Bacterial gastroenteritis UltraGene Assay Dengue differentiation DeepChek® Assay TK / POL Drug Resistance DeepChek® Assay NS5B / 5'UTR Genotyping UltraGene Assay Gonorrhoea confirmation UltraGene Assay Bordetella UltraGene Assay Clostridium Triplex DeepChek® Assay Whole Genome Influenza A Genotyping UltraGene Assay ACE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198