FDA.reportPublic FDA data

ESR Control Cube

Primary DI
08033891328757
Brand
ESR Control Cube
Company
DIESSE DIAGNOSTICA SENESE SPA
Model
10436
Catalog number
10436
Published
2022-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JPHTest, Erythrocyte Sedimentation Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPHTest, Erythrocyte Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033891328757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033891328757080338913287578033891328757

GMDN Terms#

Term, Definition table
TermDefinition
Erythrocyte sedimentation rate (ESR) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435036669
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
00810160810414Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
10810160810411Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
00860011967712ZELLESR-10STERILE SAFEQUIP & CHEMICALS LLPJPH2024-07-07
00840095624572Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682404Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095624565Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682411Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
04038917088138ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917135047ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085205ESR rack for Monovette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085304ESR rack for S-Sedivette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085311ESR rack for Microvette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917169943ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917207607ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
08033891321017ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891321048ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891328207ESR Control CubeDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
29120017578172VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578189VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578179VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578186VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578158VacuetteGreiner Bio-One GmbHJPH2020-09-25
39120017578155VacuetteGreiner Bio-One GmbHJPH2020-09-25
07612964013106DISPETTE®Guest Scientific AGJPH2020-06-01
07612964013113DISPETTE®Guest Scientific AGJPH2020-06-01
07612964000762DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013304DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013328DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013403DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013533DISPETTE®Guest Scientific AGJPH2019-11-07