21 results
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29ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc.·April 2, 2014
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc.·May 14, 2014
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
MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc·June 12, 2019
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc·June 12, 2019
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc.·February 24, 2016
D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc.·February 3, 2016
PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories Inc·August 1, 2018
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
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
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 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc.·October 20, 2021
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