FDA.reportPublic FDA data

Multiplex analyser IVD, laboratory, semi-automated

Definition
A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software. It operates with reduced technician involvement and automation of some, but not all, procedural steps.
GUDID devices
30
Last updated
2021-03-08 09:16:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840487101780xMAP® Sheath Concentrate PLUSLUMINEX CORPORATION40-500362021-02-26
00840487100080ARIES® M1 SystemLUMINEX CORPORATIONARIES M6V12016-09-09
00840487100097xMAP® Sheath FluidLUMINEX CORPORATION40-500002016-09-09
00840487100103xMAP® Sheath Concentrate PackLUMINEX CORPORATION40-756802016-09-09
00840487100110Luminex® 100/200™LUMINEX CORPORATIONLuminex 100/2002016-09-09
00840487100264MAGPIX®LUMINEX CORPORATIONMAGPIX2016-09-09
00840487100271MAGPIX® Calibration KitLUMINEX CORPORATIONMPXIVD-CAL-K252016-09-09
00840487100288MAGPIX® Performance Verification KitLUMINEX CORPORATIONMPXIVD-PVER-K252016-09-09
00840487100301FLEXMAP 3D®LUMINEX CORPORATIONFLEXMAP 3D2016-09-09
00840487100332Luminex® 100/200™ Performance Verification KitLUMINEX CORPORATIONLX200-CON-K252016-09-09
00840487100349Luminex® 100/200™ Calibration KitLUMINEX CORPORATIONLX200-CAL-K252016-09-09
00840487100356FLEXMAP 3D® Performance Verification KitLUMINEX CORPORATIONF3DIVD-PVER-K252016-09-09
00840487100363FLEXMAP 3D® Calibration KitLUMINEX CORPORATIONF3DIVD-CAL-K252016-09-09
00840487101421MAGPIX® Drive FluidLUMINEX CORPORATIONMPXDF-4PK-12016-09-09
00840487101537ARIES® SystemLUMINEX CORPORATIONARIES M12V12016-09-09
00840487101766VERIGENE® II SystemLUMINEX CORPORATIONVERIGENE-II-6M-IVD2019-12-17
00840487101773VERIGENE® II ModuleLUMINEX CORPORATIONCN-0425-012019-12-17
10888234401124LIFECODES FluoroanalyzerIMMUCOR GTI DIAGNOSTICS, INC.8883022016-09-15
00857573006003 Verigene® Reader NANOSPHERE, INC.10-0000-022016-09-23
00857573006010 Verigene® Processor SP NANOSPHERE, INC.10-0000-072016-09-23
00857573006386 Verigene® Processor NANOSPHERE, INC.10-0000-042016-09-23
00857573006393 Verigene® Reader (Refurbished)NANOSPHERE, INC.10-0000-02R2016-11-04
00857573006409 Verigene® Processor SP (Refurbished)NANOSPHERE, INC.10-0000-07R2016-11-04
00690286000018PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.6040182016-09-16
00690286000049PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.6040222016-09-16
00690286000063MEDTOXScan® ReaderMEDTOX DIAGNOSTICS, INC.8330732016-09-24
00690286000070MEDTOXScan® QC Test DevicesMEDTOX DIAGNOSTICS, INC.8330752016-09-24
00690286000087MEDTOXScan® Cleaning CassetteMEDTOX DIAGNOSTICS, INC.8330762016-09-24
10690286000022PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.6040192016-09-16
10690286000053PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.6040282016-09-16