FDA.reportPublic FDA data

CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH

Primary DI
08033891322748
Brand
CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH
Company
DIESSE DIAGNOSTICA SENESE SPA
Model
82306
Catalog number
82306
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MCBAntigen, C. Difficile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCBAntigen, C. DifficileMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033891322748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033891322748080338913227488033891322748

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435036669
Device count
1
Kit
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
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
08033891322434CHORUS MEASLES IgG81072810722024-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733101687PREMIER C. difficile GDHMERIDIAN BIOSCIENCE, INC.MCB2020-09-21
00840733101793ImmunoCard C. difficile GDHMERIDIAN BIOSCIENCE, INC.MCB2020-08-11
03573026444204VIDAS® C. difficile GDHBIOMERIEUX SAMCB2019-11-19
00857031002141C. DIFF QUIK CHEKTECHLAB, INC.MCB2018-09-28
05391516747936Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516747998Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516748841Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516748858Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516747950Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18
05391516748797Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18
05391516748803Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18