BEUDAMED
    27 results · 26ms · Sources: EU EUDAMED, US FDA

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    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PEP·February 15, 2022

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZZ·February 20, 2019

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·December 10, 2018

    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·June 5, 2023

    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PAM·November 7, 2023

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code QJR·September 14, 2022

    Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·April 5, 2022

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PGI·February 20, 2019

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

    VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·March 18, 2021

    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·June 17, 2022

    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZN·June 5, 2023

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZE·February 20, 2019

    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZN·February 20, 2019