FDA.reportPublic FDA data

FlexLab

Primary DI
07640172340004
Brand
FlexLab
Company
Inpeco SA
Model
FLX
Device description
The FlexLab 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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121012000FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.2012-08-31CEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
7640172340509PackageGS11In Commercial Distribution
07640172340004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7640172340509076401723405097640172340509
07640172340004076401723400047640172340004

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVD, automatedA mains electricity (AC-powered) instrument or platform intended to be used for the 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. The device operates with minimal technician involvement and automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
484880690
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640172345016FlexPath BloxFPB2026-02-11
07640172344002FlexLab XFXX2024-07-30
07640172341001Accelerator a3600ACP2016-09-24
07640172342008Aptio AutomationAP22016-09-24
07640172343012ProTubePTB2022-02-08
07640172343005ProTubePTB2020-09-11
7640172341506Accelerator a3600ACP2016-09-24
7640172342503Aptio AutomationAP22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESCEM2025-10-08
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CEM2020-04-15
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONCEM2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONCEM2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCEM2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCEM2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCEM2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCEM2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONCEM2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONCEM2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003043Na/K/Cl Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONCEM2018-12-04