FDA.reportPublic FDA data

ScheBo® Pancreatic Elastase 1™

Primary DI
04260152080701
Brand
ScheBo® Pancreatic Elastase 1™
Company
ScheBo r. Biotech Aktiengesellschaft
Model
ELISA Stool Test
Catalog number
07
Published
2020-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
04260152080701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260152080701042601520807014260152080701

GMDN Terms#

Term, Definition table
TermDefinition
Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of pancreatic elastase (PE) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
326980364
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260152082804ScheBo Master Quick-PrepStool-Extraction System28-Quick2023-06-12
04260152080206ScheBo® Extraction buffer5x022020-08-30

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
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
B24230PANHUE010Pancreatic Elastase ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNN2020-07-17
EBUHBKPELARSET0BÜHLMANN fPELA® turbo Reagent KitBühlmann Laboratories AGJNN2020-06-22