BEUDAMED
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    NUCLEIX LTD.

    FDA registration
    NUCLEIX LTD.·1 product·🇮🇱 Israel

    Bladder EpiCheck Test Kit

    FDA UDI
    NUCLEIX LTD·07290019028208·

    Bladder EpiCheck Extraction Kit

    FDA UDI
    NUCLEIX LTD·07290019028000·

    COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·March 3, 2022

    COBAS® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·April 5, 2022

    COBAS® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·June 16, 2022

    COBAS® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·February 28, 2023

    COBAS® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·February 28, 2023

    COBAS® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·February 28, 2023

    COBAS® SARS-COV-2 ¿ 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·May 5, 2022

    Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO

    FDA Recall
    Open, Classified ·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025

    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

    FDA Recall
    Open, Classified ·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025