FDA.reportPublic FDA data

BÜHLMANN fPELA® turbo Reagent Kit

Primary DI
EBUHBKPELARSET0
Brand
BÜHLMANN fPELA® turbo Reagent Kit
Company
Bühlmann Laboratories AG
Model
B-KPELA-RSET
Device description
The BÜHLMANN fPELA® turbo is an in vitro diagnostic test for the quantitative determination of pancreatic elastase in human fecal extracts. The results can be used as an aid to determination of exocrine pancreatic insufficiency in patients suffering from conditions such as chronic pancreatitis in conjunction with other laboratory and clinical findings. The BÜHLMANN fPELA® turbo assay is intended to be run on clinical chemistry analyzers.
Published
2020-06-22
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
EBUHBKPELARSET0PrimaryHIBCC0

GMDN Terms#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481261006
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
EBUHKKACK20BÜHLMANN ACE KineticKK-ACK2KK-ACK22025-06-27
EBUHKKACK21ACE Kinetic KitKK-ACK2KK-ACK22016-09-01
EBUHBCCRLYR20CAST® Lysing Reagent BasophilB-CCR-LYR202025-03-04
EBUHBCCRSR20CAST® Staining Reagent BasophilB-CCR-SR202025-03-04
EBUHBCCRSTB5CAST® Stimulation Buffer BasophilB-CCR-STB52025-03-04
EBUHBCCRSTCON10CAST® Stimulation Control BasophilB-CCR-STCON102025-03-04
EBUHBCCRWB10CAST® Wash Buffer BasophilB-CCR-WB102025-03-04
EBUHBKCALRSETUS0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET-US2023-05-02
04260714340007fCAL turbo089103671902022-06-13
EBUHBCALSAMPLER250Simple Sampler Stool Collection SetB-CAL-SAMPLER252023-06-26
EBUHBKPELACONSET0BÜHLMANN fPELA® turbo Control KitB-KPELA-CONSET2020-06-22
EBUHKPELACASET0BÜHLMANN fPELA® turbo Calibrator KitB-KPELA-CASET2020-06-22
07613336169926fCAL turbo089103321902020-05-27
EBUH089104991900fCAL Calibrator Set089104991902020-05-27
EBUHBEKCAL0BÜHLMANN fCAL® ELISAEK-CAL2019-11-06
EBUHBEKCAL20BÜHLMANN fCAL® ELISAEK-CAL22019-11-06
EBUHBKCALCASET0BÜHLMANN fCAL® turbo Calibrator KitB-KCAL-CASET2019-11-01
EBUHBKCALRSET0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET2019-11-01
EBUHBIPOCTRABS0Quantum Blue® ReaderBI-POCTR-ABS2021-01-12
EBUH089109870010CALEX Cap089109870012020-05-27

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
04260152080701ScheBo® Pancreatic Elastase 1™ScheBo r. Biotech AktiengesellschaftJNN2020-08-30
B24230PANHUE010Pancreatic Elastase ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNN2020-07-17