FDA.reportPublic FDA data

VES-MATIC ORIGINAL

Primary DI
08033891324551
Brand
VES-MATIC ORIGINAL
Company
DIESSE DIAGNOSTICA SENESE SPA
Model
10340
Catalog number
10340
Published
2023-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GKBDevice, Automated Sedimentation Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKBDevice, Automated Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033891324551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033891324551080338913245518033891324551

GMDN Terms#

Term, Definition table
TermDefinition
Erthrocyte sedimentation rate (ESR) analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435036669
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
08033891322571CHORUS CLEANING SOLUTION 200083609836092026-03-23
08033891322588ENZY-WELL/CHORUS WASHING BUFFER83606836062026-03-23
08033891322595CHORUS NEGATIVE CONTROL/SAMPLE DILUENT83607836072026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFER82050820502026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTION82052820522026-03-23
08033891323103CHORUS WASHING BUFFER AUTOIMMUNITY86004860042026-03-23
08033891328849CHORUS SANITIZING SOLUTION83604836042026-03-23
08033891322748CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH82306823062025-08-19
08033891322779CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS82308823082025-08-19
08033891322670CHORUS EVO82000820002025-07-01
08033891322786CHORUS FECAL ELASTASE86114861142025-07-01
08033891328474CHORUS CLIA FECAL ELASTASE82304823042025-07-01
08033891328481CHORUS ELASTASE COPROCOLLECT86116861162025-07-01
08033891320010CHORUS ECHINOCOCCUS IgG81284812842024-01-22
08033891320522VACU-TEC10200102002024-01-22
08033891320645VACU-TEC CUVETTE-L10208102082024-01-22
08033891320690VES-TEC CUVETTE-L10214102142024-01-22
08033891321086VACU-TEC S.C.10600106002024-01-22
08033891321093VACU-TEC S.C. STERILE10602106022024-01-22
08033891322083CHORUS Q FEVER PHASE II IgG81171811712024-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719189137781StarrsedMechatronics USA LLCGKB2024-08-26
00860011967736ZBT-ESRSTERILE SAFEQUIP & CHEMICALS LLPGKB2024-07-09
00868556000208ESR STAT 6Airscan, Inc.GKB2024-06-04
00850028040041iSED EliteALCOR SCIENTIFIC INC.GKB2023-11-03
03661540300288Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300202Monosed® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300257Excyte® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300264Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
03661540300271Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
08719189137132Starrsed Cleaning AgentRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137217Starrsed Rinse SolutionRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137224Starrsed X-CleanRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137231Starrsed DisinfectantRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137200Starrsed SalineRR Mechatronics Manufacturing B.V.GKB2023-07-24
06936895301097BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GKB2023-07-05
08719189137118Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137125Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137149Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137170Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137286StarrsedMechatronics USA LLCGKB2022-12-05
08719189137293StarrsedMechatronics USA LLCGKB2022-12-05