14 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories·April 3, 2024
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·June 8, 2022
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
CMV IgM EIA, in vitro diagnostic.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc·July 10, 2019
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·September 30, 2020
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·March 23, 2022
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·November 24, 2021
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·March 23, 2022
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·May 25, 2022
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·November 24, 2021
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·May 17, 2023
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023