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Sources: EU EUDAMED, US FDA
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25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
FDA Enforcement
Class II
·Terminated·IDS (Immunodiagnostic Systems Ltd.)·January 23, 2013
MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.
FDA Enforcement
Class III
·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018
CMV IgM EIA, in vitro diagnostic.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.
FDA Enforcement
Class II
·Ongoing·Hycor Biomedical LLC·November 6, 2019
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 2, 2020
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 2, 2020
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories·September 26, 2012
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 13, 2025
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
FDA Enforcement
Class II
·Completed·Bio-Rad Labs·May 6, 2020
Parvovirus B19 IgG EIA kit Part No. V519IGUS
FDA Enforcement
Class II
·Ongoing·Diasorin Inc.·September 9, 2020
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
FDA Enforcement
Class II
·Terminated·Diagnostic Hybrids, Inc.·May 16, 2018
MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
FDA Enforcement
Class III
·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·December 8, 2021
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·April 25, 2018
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
FDA Enforcement
Class III
·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·December 14, 2016
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
FDA Enforcement
Class III
·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
FDA Enforcement
Class II
·Terminated·DRG International, Inc.·April 13, 2022
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
FDA Enforcement
Class II
·Terminated·Diagnostic Hybrids Inc·September 9, 2015
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·March 17, 2021