FDA.reportPublic FDA data

CHORUS CLIA FECAL ELASTASE

Primary DI
08033891328474
Brand
CHORUS CLIA FECAL ELASTASE
Company
DIESSE DIAGNOSTICA SENESE SPA
Model
82304
Catalog number
82304
Published
2025-07-01
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
JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), TrypsinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033891328474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033891328474080338913284748033891328474

GMDN Terms#

Term, Definition table
TermDefinition
Pancreatic elastase (PE) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid in the diagnosis of conditions associated with pancreatic insufficiency (e.g., chronic pancreatitis).

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
Premarket exempt
true
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
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
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
04049095070495RIDASCREEN® Pancreatic Elastase ELISAR-Biopharm AGJNN2026-03-26
08033891322786CHORUS FECAL ELASTASEDIESSE DIAGNOSTICA SENESE SPAJNN2025-07-01
08033891328481CHORUS ELASTASE COPROCOLLECTDIESSE DIAGNOSTICA SENESE SPAJNN2025-07-01
B24280PANHUFCSET0Pancreatic Elastase CLIA Re-Calibrator and Control SetAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNN2025-06-06
B24280PANHUFC1000ALPCO Pancreatic Elastase CLIAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNN2024-07-25
04050598008540IDK® Pancreatic Elastase ELISAImmundiagnostik AGJNN2023-06-21
04050598010420IDK® Pancreatic Elastase ELISAImmundiagnostik AGJNN2023-06-21
B24280PANHUCH010Pancreatic Elastase Chemiluminescence ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNN2022-09-09
B24280PANHUCH500Pancreatic Elastase Chemiluminescence ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNN2022-09-09
04260152080701ScheBo® Pancreatic Elastase 1™ScheBo r. Biotech AktiengesellschaftJNN2020-08-30
B24230PANHUE010Pancreatic Elastase ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNN2020-07-17
EBUHBKPELARSET0BÜHLMANN fPELA® turbo Reagent KitBühlmann Laboratories AGJNN2020-06-22