FDA.reportPublic FDA data

Fontus

Primary DI
00812589021082
Brand
Fontus
Company
Caliper Life Sciences, Inc.
Model
CFM8L01
Catalog number
CFM8L01
Device description
Fontus LH, Standard, 8-384, IVD
Published
2024-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00812589021082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589021082008125890210828125890210820812589021082

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

Regulatory Flags#

DUNS number
933210197
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812589020979FontusCFL8H02CFL8H022024-07-02
00812589021051FontusCFL8L02CFL8L022024-07-02
00812589021068FontusCFM8H01CFM8H012024-07-02
00812589021075FontusCFL8H01CFL8H012024-07-02
00812589021099FontusCFL8L01CFL8L012024-07-02
00812589021129FontusCFL8001CFL80012024-07-02
00812589021136FontusCFM8001CFM80012024-07-02
00812589020993Janus G3 Automated WorkstationCJM8M032024-01-30
00812589021020Janus G3 Automated WorkstationCJS80032024-01-30
00812589021273Janus G3 Automated WorkstationCJSM0032024-01-30
00812589020931JANUS G3CJM80032022-02-24
00812589020580JANUS G3CJM80022022-01-20
00812589020597JANUS G3CJL80022022-01-20
00812589020603JANUS G3 NGS ExpressCJS4NGS2022-01-20
00812589020610JANUS G3 Blood iQCJM8GB52022-01-20
00812589020627JANUS G3 Blood iQCJM80B52022-01-20
00812589020634JANUS G3 Blood iQCJL8GB52022-01-20
00812589020641JANUS G3 Blood iQCJL80B52022-01-20
00812589020658JANUS G3CJL8M022022-01-20
00812589020665JANUS G3CJS80012022-01-20

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
00812589021099FontusCaliper Life Sciences, Inc.JQW2024-07-02