FDA.reportPublic FDA data

Fluent®

Primary DI
07640137481100
Brand
Fluent®
Company
Tecan Schweiz AG
Model
INSTRUMENT FLUENT 480 BASE UNIT
Catalog number
30042011
Device description
configurable liquid handling workstation
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQWStation, Pipetting And Diluting, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640137481100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640137481100076401374811007640137481100

GMDN Terms#

Term, Definition table
TermDefinition
Pipetting system IVDAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41449228282helpdesk-ch@tecan.com

Regulatory Flags#

DUNS number
481151509
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640137480288Veya Dx 6Veya Dx 6302462172025-03-31
07640137480295Veya Dx 9Veya Dx 9302462182025-03-31
07640137481117Fluent®INSTRUMENT FLUENT 780 BASE UNIT300420212020-11-16
07640137481124Fluent®INSTRUMENT FLUENT 1080 BASE UNIT300420312020-11-16
07640137480011Freedom EVO 75FREEDOM EVO 75300250192021-12-22
07640137480028Freedom EVO 75FREEDOM EVO 75300258692021-12-22
07640137480042Freedom EVO®FREEDOM EVO-2 100 BASE106411002021-12-22
07640137480066Freedom EVO®FREEDOM EVO-2 150 BASE106411502021-12-22
07640137480080Freedom EVO®FREEDOM EVO-2 200 BASE106412002021-12-22
07640137480103Freedom EVO®FREEDOM EVO-2 150 BASE106411522021-12-22
07640137480110Freedom EVO®FREEDOM EVO-2 200 BASE106412022021-12-22
07640137480127Freedom EVO®FREEDOM EVO-2 100 BASE300200102021-12-22
07640137480134Freedom EVO®FREEDOM EVO-2 150 BASE300200152021-12-22
07640137480141Freedom EVO®FREEDOM EVO-2 200 BASE300200202021-12-22
07640137480349Freedom EVO®FREEDOM EVO-2 100 BASE300320102021-12-22
07640137480356Freedom EVO®FREEDOM EVO-2 150 BASE300320152021-12-22
07640137480363Freedom EVO®FREEDOM EVO-2 200 BASE300320202021-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026392Diagnostic Automation, Inc.Diagnostic Automation, Inc.JQW2025-12-24
08059304340147dIFine P15VISIA LAB SRLJQW2025-06-27
00884999051522Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999048973Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051508Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051515Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051720Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
06975379910028QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910035QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910509QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910025QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910032QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910506QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910011QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
16975379910018QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
06975379910004QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-12
07640137480288Veya Dx 6Tecan Schweiz AGJQW2025-03-31
07640137480295Veya Dx 9Tecan Schweiz AGJQW2025-03-31
07613336180112AVENIO Edge SystemRoche Molecular Systems, Inc.JQW2025-03-25
00819704020388FINDERBaebies, Inc.JQW2025-01-31
00819704020395FINDERBaebies, Inc.JQW2025-01-31
07613336155790AcfS L and D Equipment Installation BundleRoche Molecular Systems, Inc.JQW2025-01-30
07613336172353AcfS Library RobotRoche Molecular Systems, Inc.JQW2025-01-30
07613336172360AcfS Detection RobotRoche Molecular Systems, Inc.JQW2025-01-30
04250289513531HELMED® Automated IFA ProcessorAesku.Diagnostics GmbH & Co. KGJQW2025-01-03
00812589020979FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021051FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021068FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021075FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021082FontusCaliper Life Sciences, Inc.JQW2024-07-02