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    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

    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 Enforcement
    Class I ·Ongoing·Universal Meditech Inc.·February 8, 2023

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    FDA Enforcement
    Class III ·Ongoing·NeuMoDx Molecular Inc·July 12, 2023

    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

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

    FDA Enforcement
    Class I ·Ongoing·INNOVA MEDICAL GROUP, INC.·June 16, 2021

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

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 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 Enforcement
    Class I ·Ongoing·North American Diagnostics·August 10, 2022

    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

    Accula SARS-CoV-2 Test, REF: COV4100

    FDA Enforcement
    Class I ·Ongoing·MESA BIOTECH, INC·May 18, 2022