FDA.reportPublic FDA data

RIDASCREEN® Pancreatic Elastase ELISA

Primary DI
04049095070495
Brand
RIDASCREEN® Pancreatic Elastase ELISA
Company
R-Biopharm AG
Model
G09038USA
Catalog number
G09038USA
Device description
Pancreatic Elastase ELISA is an IVD test for the quantitative determination of pancreatic elastase in stool samples of human origin by a laboratory professional user.
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04049095070495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049095070495040490950704954049095070495

GMDN Terms#

Term, Definition table
TermDefinition
Pancreatic elastase (PE) IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen.

Regulatory Flags#

DUNS number
321850323
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
04049095030079RIDASCREEN® Norovirus 3rd GenerationC1401USC1401US2019-05-08
04049095160356RIDA®GENE Norovirus GI/GIIPG1445PG14452019-05-08
04049095260049RIDA® CCD-InhibitorZA06012023-07-03
04049095110023RIDASCREEN® Entamoeba histolytica IgGK1721K17212019-05-08
04049095110511RIDASCREEN® Echinococcus IgGK7621K76212019-05-08
04049095110528RIDASCREEN® Taenia solium IgGK7721K77212019-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891322786CHORUS FECAL ELASTASEDIESSE DIAGNOSTICA SENESE SPAJNN2025-07-01
08033891328474CHORUS CLIA 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