FDA.report

Pipetting system IVD

Definition
An electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities.
GUDID devices
82
Last updated
2026-02-17 23:01:50

Related Product Codes

CodeDeviceSpecialtyClassDevices
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry170
OTVResearch Use Only/Clinical Chemistry DevicesUnknownN6
JJHClinical Sample ConcentratorClinical Chemistry14
PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisClinical Chemistry11
QBZAutomated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or PlasmaClinical Chemistry11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00858637005895Cologuard Capture AspiratorEXACT SCIENCES CORPORATION3004902022-12-08
07640137480288Veya Dx 6Tecan Schweiz AGVeya Dx 62025-03-31
07640137480295Veya Dx 9Tecan Schweiz AGVeya Dx 92025-03-31
07613336155790AcfS L and D Equipment Installation BundleRoche Molecular Systems, Inc.077592740012025-01-30
07613336172353AcfS Library RobotRoche Molecular Systems, Inc.077593710012025-01-30
07613336172360AcfS Detection RobotRoche Molecular Systems, Inc.077593630012025-01-30
00860012318230XpeedyCura Diagnostics Inc.DOA202024-07-19
00812589020979FontusCaliper Life Sciences, Inc.CFL8H022024-07-02
00812589021051FontusCaliper Life Sciences, Inc.CFL8L022024-07-02
00812589021068FontusCaliper Life Sciences, Inc.CFM8H012024-07-02
00812589021075FontusCaliper Life Sciences, Inc.CFL8H012024-07-02
00812589021082FontusCaliper Life Sciences, Inc.CFM8L012024-07-02
00812589021099FontusCaliper Life Sciences, Inc.CFL8L012024-07-02
00812589021129FontusCaliper Life Sciences, Inc.CFL80012024-07-02
00812589021136FontusCaliper Life Sciences, Inc.CFM80012024-07-02
06975141982086CURACura Diagnostics Inc.Xpeedy DOA202024-05-30
00812589020993Janus G3 Automated WorkstationCaliper Life Sciences, Inc.CJM8M032024-01-30
00812589021020Janus G3 Automated WorkstationCaliper Life Sciences, Inc.CJS80032024-01-30
00812589021273Janus G3 Automated WorkstationCaliper Life Sciences, Inc.CJSM0032024-01-30
07640137481100Fluent®Tecan Schweiz AGINSTRUMENT FLUENT 480 BASE UNIT2020-11-16
07640137481117Fluent®Tecan Schweiz AGINSTRUMENT FLUENT 780 BASE UNIT2020-11-16
07640137481124Fluent®Tecan Schweiz AGINSTRUMENT FLUENT 1080 BASE UNIT2020-11-16
58059796361700URIVerse™COPAN WASP SRLW0952023-10-20
M52513410000Electrophoresis Handler, CE VersionHELENA LABORATORIES CORPORATION13410002017-03-17
M52513410010ESH, "CE", (New Pump)HELENA LABORATORIES CORPORATION13410012017-03-17
M52513410020ESH, "CE", (New Computer)HELENA LABORATORIES CORPORATION13410022017-03-17
M52513800000ESH Touch (120/230V)HELENA LABORATORIES CORPORATION13800002017-03-17
08809240109007Seegene STARletSEEGENE, INC.12022-12-05
08809240109014Seegene NIMBUSSEEGENE, INC.12022-12-05
04987562501908Sample Preparation System PS-10SYSMEX CORPORATIONPS-102022-11-30
58052870818923External Loader - Turn TableCOPAN WASP SRLW093-102022-05-26
00812589020931JANUS G3Caliper Life Sciences, Inc.CJM80032022-02-24
00812589020580JANUS G3Caliper Life Sciences, Inc.CJM80022022-01-20
00812589020597JANUS G3Caliper Life Sciences, Inc.CJL80022022-01-20
00812589020603JANUS G3 NGS ExpressCaliper Life Sciences, Inc.CJS4NGS2022-01-20
00812589020610JANUS G3 Blood iQCaliper Life Sciences, Inc.CJM8GB52022-01-20
00812589020627JANUS G3 Blood iQCaliper Life Sciences, Inc.CJM80B52022-01-20
00812589020634JANUS G3 Blood iQCaliper Life Sciences, Inc.CJL8GB52022-01-20
00812589020641JANUS G3 Blood iQCaliper Life Sciences, Inc.CJL80B52022-01-20
00812589020658JANUS G3Caliper Life Sciences, Inc.CJL8M022022-01-20
00812589020665JANUS G3Caliper Life Sciences, Inc.CJS80012022-01-20
00812589020672JANUS G3Caliper Life Sciences, Inc.CJSM0012022-01-20
00812589020689JANUS G3Caliper Life Sciences, Inc.CJS40012022-01-20
00812589020696JANUS G3Caliper Life Sciences, Inc.CJMMG012022-01-20
00812589020702JANUS G3Caliper Life Sciences, Inc.CJMM0012022-01-20
00812589020719JANUS G3Caliper Life Sciences, Inc.CJM8M012022-01-20
00812589020726JANUS G3Caliper Life Sciences, Inc.CJM8G012022-01-20
00812589020733JANUS G3Caliper Life Sciences, Inc.CJM80012022-01-20
00812589020740JANUS G3Caliper Life Sciences, Inc.CJM4G012022-01-20
00812589020757JANUS G3Caliper Life Sciences, Inc.CJM4M012022-01-20
00812589020764JANUS G3Caliper Life Sciences, Inc.CJM40012022-01-20
00812589020771JANUS G3Caliper Life Sciences, Inc.CJLMG012022-01-20
00812589020788JANUS G3Caliper Life Sciences, Inc.CJLM0012022-01-20
00812589020795JANUS G3Caliper Life Sciences, Inc.CJL8M012022-01-20
00812589020801JANUS G3Caliper Life Sciences, Inc.CJL8G012022-01-20
00812589020818JANUS G3Caliper Life Sciences, Inc.CJL80012022-01-20
00812589020825JANUS G3Caliper Life Sciences, Inc.CJL4M012022-01-20
00812589020832JANUS G3Caliper Life Sciences, Inc.CJL4G012022-01-20
00812589020849JANUS G3Caliper Life Sciences, Inc.CJL40012022-01-20
00812589020856JANUS G3Caliper Life Sciences, Inc.CJIMG012022-01-20
00812589020863JANUS G3Caliper Life Sciences, Inc.CJIM0012022-01-20
00812589020870JANUS G3Caliper Life Sciences, Inc.CJI8M012022-01-20
00812589020887JANUS G3Caliper Life Sciences, Inc.CJI8G012022-01-20
00812589020894JANUS G3Caliper Life Sciences, Inc.CJI80012022-01-20
00812589020900JANUS G3Caliper Life Sciences, Inc.CJI4M012022-01-20
00812589020917JANUS G3Caliper Life Sciences, Inc.CJI4G012022-01-20
00812589020924JANUS G3Caliper Life Sciences, Inc.CJI40012022-01-20
07640137480011Freedom EVO 75Tecan Schweiz AGFREEDOM EVO 752021-12-22
07640137480028Freedom EVO 75Tecan Schweiz AGFREEDOM EVO 752021-12-22
07640137480042Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 100 BASE2021-12-22
07640137480066Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 150 BASE2021-12-22
07640137480080Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 200 BASE2021-12-22
07640137480103Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 150 BASE2021-12-22
07640137480110Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 200 BASE2021-12-22
07640137480127Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 100 BASE2021-12-22
07640137480134Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 150 BASE2021-12-22
07640137480141Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 200 BASE2021-12-22
07640137480349Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 100 BASE2021-12-22
07640137480356Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 150 BASE2021-12-22
07640137480363Freedom EVO®Tecan Schweiz AGFREEDOM EVO-2 200 BASE2021-12-22