BEUDAMED
    26 results · 12ms · Sources: EU EUDAMED, US FDA

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    Diagnostic Kit SARS-cCo V Antigen Rapid Test

    FDA Recall
    Open, Classified ·USA Medical, LLC·Product code QKP·April 4, 2022

    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

    FDA Recall
    Open, Classified ·Acon Biotech (Hangzhou) Co., Ltd.·Product code QKP·January 9, 2022

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Recall
    Open, Classified ·CELLTRION USA INC·Product code QKP·February 25, 2022

    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

    FDA Recall
    Open, Classified ·Migo Trading LLC·Product code QKP·November 4, 2021

    Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

    FDA Recall
    Open, Classified ·Cellex·Product code QKP·March 1, 2021

    Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    FDA Recall
    Open, Classified ·Woodside Acquisitions Inc.·Product code QKP·April 9, 2022

    Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

    FDA Recall
    Open, Classified ·LUMINOSTICS, INC dba CLIP HEALTH·Product code QKP·September 2, 2022

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code QKP·November 28, 2022

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    FDA Recall
    Open, Classified ·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·March 31, 2023

    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

    FDA Recall
    Open, Classified ·North American Diagnostics·Product code QKP·June 15, 2022

    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

    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

    FDA Recall
    Open, Classified ·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·January 31, 2022

    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    FDA Recall
    Open, Classified ·SML Distribution, LLC·Product code QKP·March 4, 2022

    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

    FDA Recall
    Open, Classified ·INNOVA MEDICAL GROUP, INC.·Product code QKP·April 9, 2021

    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    Detect Covid-19 Test Product/Model Number: 21205

    FDA Recall
    Open, Classified ·Detect Headquarters·Product code QKP·December 8, 2022

    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

    FDA Recall
    Open, Classified ·Jiangsu Well Biotech Co., Ltd. No·Product code QKP·August 9, 2022

    Ellume COVID-19 Home Test

    FDA Recall
    Open, Classified ·ELLUME LTD 57 Didsbury St East Brisbane Australia·Product code QKP·October 1, 2021

    COVID-19 Self-Test Kit *** INNOVA *** 3T

    FDA Recall
    Open, Classified ·INNOVA MEDICAL GROUP, INC.·Product code QKP·April 9, 2021