49 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
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
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
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
CMV IgM EIA, in vitro diagnostic.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·May 25, 2022
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
FDA Enforcement
Class I
·Ongoing·Lusys Laboratories, Inc.·March 16, 2022
Mycoplasma test, IgG and IgM
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
VIDAS Lyme IgM II (LYM), REF 416436
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS SARS-COV-2 IgM, Ref 423833-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·February 14, 2024
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
FDA Enforcement
Class II
·Ongoing·Zeus Scientific, Inc.·December 27, 2023
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·July 31, 2024
cobas e801 Immunoassay Analyzer
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·March 27, 2024
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·December 18, 2019
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
FDA Enforcement
Class II
·Ongoing·Hycor Biomedical Inc·August 14, 2019