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    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM

    FDA Enforcement
    Class III ·Terminated·Bio-rad Laboratories, Inc.·May 22, 2013

    Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 18, 2019

    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

    FDA Enforcement
    Class II ·Ongoing·Quest International, Inc.·September 17, 2025

    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Completed·Hycor Biomedical Inc·August 7, 2019

    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·July 10, 2019

    SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·January 10, 2024

    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only, and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.

    FDA Enforcement
    Class II ·Terminated·AZURE BIOTECH INC·April 28, 2021

    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 25, 2015

    Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 6, 2019

    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·May 17, 2023

    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·September 10, 2025

    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 23, 2024

    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·December 19, 2018

    PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)

    FDA Enforcement
    Class III ·Terminated·Phadia US Inc·September 5, 2012

    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.

    FDA Enforcement
    Class III ·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 24, 2014

    IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·December 14, 2022

    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·November 28, 2018

    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·October 19, 2016

    ADVIA Centaur¿ HBc IgM

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics·July 19, 2023