BEUDAMED
    76 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100

    FDA Enforcement
    Class II ·Ongoing·NeuMoDx Molecular Inc·May 4, 2022

    ARIES SARS-CoV-2 Assay

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 24, 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 Enforcement
    Class II ·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025

    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc.·January 1, 2025

    cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·April 21, 2021

    QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·August 2, 2023

    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

    FDA Enforcement
    Class II ·Ongoing·Quidel Corporation·February 21, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Acon Biotech (Hangzhou) Co., Ltd.·April 27, 2022

    Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·February 1, 2023

    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·April 21, 2021

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

    FDA Enforcement
    Class II ·Ongoing·NeuMoDx Molecular Inc·June 15, 2022

    DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

    FDA Enforcement
    Class II ·Ongoing·NeuMoDx Molecular Inc·March 16, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·November 2, 2022

    BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·June 12, 2024

    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.

    FDA Enforcement
    Class II ·Ongoing·Nuclein LLC·August 13, 2025

    VIDAS SARS-COV-2 IgM, Ref 423833-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS SARS-COV-2 IgG, Ref 423834-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·June 14, 2023

    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

    FDA Enforcement
    Class II ·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024