FDA.reportPublic FDA data

Specimen processing instrument IVD, automated

Definition
A mains electricity (AC-powered) instrument or platform intended to be used for the automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. The device operates with minimal technician involvement and automation of all procedural steps.
GUDID devices
52
Last updated
2022-09-08 06:23:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04053228039129QIAcube Connect MDxQIAGEN GmbH12022-08-31
00382906631282BD FACSDuetBecton, Dickinson And Company6631282022-08-23
07640172341001Accelerator a3600Inpeco SAACP2016-09-24
07640172342008Aptio AutomationInpeco SAAP22016-09-24
01812125010074AcuitasOpgen, Inc.AC0432021-10-25
04015630929061cobas p 501 post-analytical unitRoche Diagnostics GmbH051584940012020-12-21
04015630929078cobas p 701 Post-Analytical UnitRoche Diagnostics GmbH053499660012020-12-21
04015630942305B-Gate InterfaceRoche Diagnostics GmbH068847500012020-12-21
07613336156520BCM for cobas 8100Roche Diagnostics GmbH083684490012020-12-21
00630414002347Atellica Direct LoadSiemens Healthcare Diagnostics Inc.110680082020-09-24
00630414002439Atellica Sample Handler PrimeSiemens Healthcare Diagnostics Inc.110690012020-09-24
00630414002460Atellica Sample Handler AdditionalSiemens Healthcare Diagnostics Inc.110690042020-09-24
00630414002354Atellica Direct Load KitSiemens Healthcare Diagnostics Inc.110680092020-09-24
15099590264765LH Slide StainerBeckman Coulter, Inc.66056452020-08-31
15099590330620LH SlidemakerBeckman Coulter, Inc.66056332020-08-31
15099590564353FP1000Beckman Coulter, Inc.6249222020-08-31
10888385000665CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.95412020-07-10
07613336171288cobas&#x00AE prime Process Plus ModuleRoche Molecular Systems, Inc.089879630012020-07-01
07613336171325cobas&#x00AE prime Pre-analytical SystemRoche Molecular Systems, Inc.089882420012020-07-01
07613336171332cobas&#x00AE prime Pre-analytical SystemRoche Molecular Systems, Inc.089882770012020-07-01
15099590707118DxA 5000Beckman Coulter, Inc.DxA 50002019-11-04
07613336158562cobas e 801 Immunoassay analyzerRoche Diagnostics GmbH084596060012019-04-25
15099590192679UniCel DxHBeckman Coulter, Inc. SMS2016-09-23
15099590364083Automate 2500 FamilyBeckman Coulter, Inc.AutoMate 25502016-08-15
15099590364090Automate 2500 FamilyBeckman Coulter, Inc.AutoMate 25002016-08-15
15099590364106Automate 2500 FamilyBeckman Coulter, Inc.AutoMate 12502016-08-15
15099590364465Automate 2500 FamilyBeckman Coulter, Inc.AutoMate 12002016-08-15
15099590563547TQ-Prep WorkstationBeckman Coulter, Inc.66054292016-09-23
15099590563554Q-Prep Beckman Coulter, Inc.115V2016-09-23
15099590563561Q-Prep Beckman Coulter, Inc.100V2016-09-23
15099590563578Q-Prep Beckman Coulter, Inc.240V2016-09-23
15099590563905Q-Prep Beckman Coulter, Inc.230V2016-09-23
15099590583996Power LinkBeckman Coulter, Inc.Power Link2016-08-15
15099590589806AutoMate 600 Sample ProcessorBeckman Coulter, Inc.AutoMate 600 Sample Processor2016-08-15
15099590589813AutoMate 800 Sample ProcessorBeckman Coulter, Inc.AutoMate 800 Sample Processor2016-08-15
15099590591960Power Processor Sample Handling SystemBeckman Coulter, Inc.Power Processor Sample Handling System2016-08-15
15099590604479Power Processor PowerCelBeckman Coulter, Inc.Power Processor PowerCel2016-08-15
15099590638191PrepPlus 2Beckman Coulter, Inc.3786002016-09-23
15099590672324Power ExpressBeckman Coulter, Inc.Power Express2016-08-15
15099590701567DxH Slidemaker Stainer IIBeckman Coulter, Inc.C114772018-05-03
04053228010746QIAsymphony ASQIAGEN GmbH12017-08-15
04053228010753EZ1 AdvancedQIAGEN GmbH12017-08-15
04053228010760EZ1 Advanced XLQIAGEN GmbH12017-08-15
04053228010821Rapid Capture SystemQIAGEN GmbH12017-08-15
07640172340004FlexLabInpeco SAFLX2016-09-24
7640172341506Accelerator a3600Inpeco SAACP2016-09-24
7640172342503Aptio AutomationInpeco SAAP22016-09-24
00630414595177VersaCell® X3SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD107938392018-09-24
00630414596754AptioTM AutomationSiemens Healthcare Diagnostics Inc.107137602018-09-24
00382903365746FACSBecton, Dickinson And Company3365742016-06-08
00382903371464FACSBecton, Dickinson And Company3371462018-11-28
00382906472052FACSBecton, Dickinson And Company6472052016-06-08