FlexLab X

GUDID 07640172344002

The FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.

Inpeco SA

Specimen processing instrument IVD
Primary Device ID07640172344002
NIH Device Record Key4fdc9523-479f-4736-bc44-e8305fad2bd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexLab X
Version Model NumberFXX
Company DUNS484880690
Company NameInpeco SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172344002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEMElectrode, Ion Specific, Potassium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-07
Device Publish Date2024-07-30

Devices Manufactured by Inpeco SA

07640172344002 - FlexLab X2024-08-07The FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.
07640172344002 - FlexLab X2024-08-07 The FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling
07640172343012 - ProTube2022-02-16 ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is
07640172341001 - Accelerator a36002021-11-12 The Accelerator a3600 automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample
07640172342008 - Aptio Automation2021-11-12 The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in
07640172343005 - ProTube2020-09-21 The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collectio
07640172340004 - FlexLab2018-07-06 The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling i
7640172341506 - Accelerator a36002018-07-06 The Accelerator a3600 automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample
7640172342503 - Aptio Automation2018-07-06 The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in
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