FDA.report

Specimen processing instrument IVD

Definition
An electrically-powered instrument or platform intended to be used for the automated or semi-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.
GUDID devices
73
Last updated
2026-03-11 21:17:10

Related Product Codes

CodeDeviceSpecialtyClassDevices
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry155
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry14
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry13
NQISystem, Immunomagnetic, Circulating Cancer Cell, EnumerationImmunology23
PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisClinical Chemistry12
CEMElectrode, Ion Specific, PotassiumClinical Chemistry21
JJHClinical Sample ConcentratorClinical Chemistry11
MAQKit, Dna Detection, Human PapillomavirusUnknown31
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry21
PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, ColonyMicrobiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
04053228040576EZ2 Connect MDxQIAGEN GmbH90032302026-03-03
15099590750312CellmekBeckman Coulter, Inc.C446032025-09-02
04250289513531HELMED® Automated IFA ProcessorAesku.Diagnostics GmbH & Co. KGREF.HEL-1000.US2025-01-03
07640172344002FlexLab XInpeco SAFXX2024-07-30
00382903364916BD FACS™BECTON, DICKINSON AND COMPANY3364912024-03-19
00382904439880BD COR™ PX INSTRUMENTBECTON, DICKINSON AND COMPANY4439882024-02-16
00380740015091ACCELERATORABBOTT LABORATORIES07L01012023-09-15
00380740028862ACCELERATORABBOTT LABORATORIES07L01022023-09-15
00380740196257GLP systems TrackABBOTT LABORATORIES04Z96512023-08-30
06438153000129Entry, TCAThermo Fisher Scientific Oy12023-07-26
06438153000143Exit, TCAThermo Fisher Scientific Oy12023-07-26
06438153000211Conveyor 600, TCAThermo Fisher Scientific Oy12023-07-26
06438153000228Conveyor 1200, TCAThermo Fisher Scientific Oy12023-07-26
06438153000235Conveyor 1500, TCAThermo Fisher Scientific Oy12023-07-26
06438153000259Conveyor 2400, TCAThermo Fisher Scientific Oy12023-07-26
06438153000266L-Turn, TCAThermo Fisher Scientific Oy12023-07-26
06438153000297Conveyor 900, TCAThermo Fisher Scientific Oy12023-07-26
06438153000303Conveyor 2100, TCAThermo Fisher Scientific Oy12023-07-26
06438153520139Buffer, TCAThermo Fisher Scientific Oy12023-07-26
06438153000099Interface, TCA ARCHITECT i2000SRThermo Fisher Scientific Oy12023-07-25
06438153000242Conveyor 1800, TCAThermo Fisher Scientific Oy12023-07-25
06438153000327Decapper Flex, TCAThermo Fisher Scientific Oy12023-07-25
06438153000358Perpendicular Bypass, TCA Vitros 5.1 FS ATThermo Fisher Scientific Oy12023-07-25
06438153000419Internal U-Turn, TCAThermo Fisher Scientific Oy12023-07-25
06438153000433Z-Turn, right, TCAThermo Fisher Scientific Oy12023-07-25
06438153000440Z-Turn, left, TCAThermo Fisher Scientific Oy12023-07-25
06438153000471Sysmex HST Interface, TCAThermo Fisher Scientific Oy12023-07-25
06438153000488Stago STA-R Interface, TCAThermo Fisher Scientific Oy12023-07-25
06438153000549Parallel Bypass, TCA Vitros 5.1 FSThermo Fisher Scientific Oy12023-07-25
06438153000587Parallel Bypass, TCA Beckman Unicel DxI 800Thermo Fisher Scientific Oy12023-07-25
06438153000594Recapper, 110V, TCAThermo Fisher Scientific Oy12023-07-25
06438153000617U-Turn MekThermo Fisher Scientific Oy12023-07-25
06438153000631Parallel Bypass, TCA Olympus AU680DTSThermo Fisher Scientific Oy12023-07-25
06438153000648Parallel Bypass, TCA TosohThermo Fisher Scientific Oy12023-07-25
06438153000655Interface, TCA ImmunoCap 1000Thermo Fisher Scientific Oy12023-07-25
06438153000662Parallel Bypass, TCA IL ACL TopThermo Fisher Scientific Oy12023-07-25
06438153000679ES Flex, TCAThermo Fisher Scientific Oy12023-07-25
06438153000822Interface, TCA ARCHITECT c8000Thermo Fisher Scientific Oy12023-07-25
06438153000839T-Turn, TCAThermo Fisher Scientific Oy12023-07-25
06438153002543Parallel Bypass, TCA Liaison XLThermo Fisher Scientific Oy12023-07-25
06438153002635TCA 800 Interface for cobas 8000Thermo Fisher Scientific Oy12023-07-25
06438153003359Parallel Bypass, TCA Tosoh G8Thermo Fisher Scientific Oy12023-07-25
06438153003489Perpendicular Bypass, TCA for Cold Storage Rack LoaderThermo Fisher Scientific Oy12023-07-25
06438153004561LoaderThermo Fisher Scientific Oy12023-07-25
06438153004592StorageThermo Fisher Scientific Oy12023-07-25
06438153007449Bulk Interface ModuleThermo Fisher Scientific Oy12023-07-25
06438153007845Centrifuge Flex Module, TCAThermo Fisher Scientific Oy12023-07-25
06438153520405Centrifuge Module, TCAThermo Fisher Scientific Oy12023-07-25
06438153520504Aliquoter & Labeler, TCAThermo Fisher Scientific Oy12023-07-25
04250289512565HELMED® AUTOMATED IFA PROCESSORAesku.Diagnostics GmbH & Co. KGREF.HEL-10002023-06-25
00382906663405BD FACSDuetBECTON, DICKINSON AND COMPANY6663402023-06-12
20812125010079AcuitasOpgen, Inc.AC0432023-04-28
04260364751000AcuitasCuretis GmbHQIAGEN® EZ1® Advanced XL System2023-04-17
04015630936540cobas p630 Pre-Analytical PipettorRoche Molecular Systems, Inc.055275030012014-09-17
08806133010068AFIAS-50Boditech Med Inc.FPRR0222017-10-19
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09356119001027PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A12032020-11-16
09356119001034PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A12042020-11-16
09356119001041PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A12052020-11-16
09356119001058PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A12062020-11-16
09356119001065PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A12072020-11-16
09356119001072PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A12082020-11-16
09356119001089PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A12102020-11-16
09356119002000PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A6052020-11-16
09356119002208PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A0702020-11-16
09356119002215PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A0692020-11-16
09356119002222PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A0842020-11-16
09356119002406PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A7102020-11-16
09356119002413PATHFINDERAIM LAB AUTOMATION TECHNOLOGIES PTY LTDPS-U-A7112020-11-16
10888385000061CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.95412016-09-22
10888385000078CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.79010032016-09-22
10888385000610CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.9541R2016-09-22