FDA.reportPublic FDA data

Enzyme immunoassay (EIA) analyser IVD

Definition
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids.
GUDID devices
31
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04049016127918EUROLabWorkstation ELISAEUROIMMUN Medizinische Labordiagnostika AGYG 0851-01012022-12-08
04260678680010GEMINISTRATEC SECompact Microplate Processor2025-09-05
00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.IN0092024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.IN0132024-09-13
08033891323981CHORUS TRIO RASDIESSE DIAGNOSTICA SENESE SPA812202023-12-14
08033891328856CHORUS TRIODIESSE DIAGNOSTICA SENESE SPA812002023-12-14
B35000300CLR0ThunderBolt EIA (CLIA)Gold Standard Diagnostics Corporation00300-CLR2023-10-31
B35000300R0ThunderBolt EIAGold Standard Diagnostics Corporation00300R2023-10-31
B35000500R0BoltGold Standard Diagnostics Corporation00500R2023-10-31
04049016159018UNIQO 160EUROIMMUN Medizinische Labordiagnostika AGYG 2900-0101-12023-09-20
B350GSD0124500Performance Check Dye KitGold Standard Diagnostics CorporationGSD01-24502023-09-13
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungHYB-52522023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncHYB-52522023-08-26
03610520013328EVOLISBIO-RAD896012023-02-03
03610520013571PR 4100BIO-RAD915872023-02-03
06925912711117UNION Immune AnalyzerShenzhen YHLO Biotech Co., Ltd.UNION-C2022-10-26
B350003000ThunderBolt EIAGold Standard Diagnostics Corporation003002022-09-24
B35000300CL0ThunderBolt EIA (CLIA)Gold Standard Diagnostics Corporation00300-CL2022-09-24
B350005000BoltGold Standard Diagnostics Corporation005002022-09-24
B35000500CL0Bolt (CLIA)Gold Standard Diagnostics Corporation00500-CL2022-09-24
04560189282896AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360TOSOH CORPORATIONAIA-3602019-09-02
04560189283992AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900TOSOH CORPORATIONAIA-9002019-09-02
045601892840059tray SorterTOSOH CORPORATIONN/A2019-09-02
0456018928401219tray SorterTOSOH CORPORATIONN/A2019-09-02
04560189284616AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 STTOSOH CORPORATIONAIA-2000 ST2019-09-02
04560189284623AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 LATOSOH CORPORATIONAIA-2000 LA2019-09-02
10758750005451ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.9363962016-08-24
10758750005581ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.9364802016-08-24
10758750011582ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.68428522016-08-24
10758750011599ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.6842852B2016-08-24
10758750013265ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.55617012016-08-24