FDA.reportPublic FDA data

Pancreatic Elastase CLIA Re-Calibrator and Control Set

Primary DI
B24280PANHUFCSET0
Brand
Pancreatic Elastase CLIA Re-Calibrator and Control Set
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
80-PANHU-FCSET
Device description
The Pancreatic Elastase CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Pancreatic Elastase CLIA kit (80-PANHU-FC100 or 80-PANHU-FC900) by trained laboratory personnel. For in vitro diagnostic use in the United States.
Published
2025-06-06
Public version status
New
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
B24280PANHUFCSET0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pancreatic elastase (PE) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection 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
784143778
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B24280LACHUFC9000ALPCO Lactoferrin CLIA Kit80-LACHU-FC90080-LACHU-FC9002026-03-31
B24230PANHUE010Pancreatic Elastase ELISA30-PANHU-E0130-PANHU-E012020-07-17
B24280EZDEV21000Unfilled Easy 2 Stool Extraction Device80-EXDEV2-10080-EXDEV2-1002026-02-02
B24280EZEX21000Easy 2 Stool Extraction Device80-EZEX2-10080-EZEX2-1002025-10-30
B24280CALPHUCH500ALPCO Calprotectin Chemiluminescence ELISA80-CALPHU-CH5080-CALPHU-CH502019-11-04
B24224MABHUE010Microalbumin ELISA24-MABHU-E0124-MABHU-E012018-01-16
B24280LACHUFCSET0Lactoferrin CLIA Re-Calibrator and Control Set80-LACHU-FCSET2025-06-06
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)25-TT4HU-E0125-TT4HU-E012017-08-03
B24211PREHUE010Pregnenolone ELISA11-PREHU-E0111-PREHU-E012020-09-25
B24280PANHUCH500Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH5080-PANHU-CH502022-09-09
B24280LACHUFC1000ALPCO Lactoferrin CLIA Kit80-LACHU-FC10080-LACHU-FC1002025-03-03
B24211HGHHUE010Human Growth Hormone ELISA11-HGHHU-E0111-HGHHU-E012025-01-20
B24280PANHUFC1000ALPCO Pancreatic Elastase CLIA80-PANHU-FC10080-PANHU-FC1002024-07-25
B24280PANHUCH010Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH0180-PANHU-CH012022-09-09
B24211GLUHUE010Glucagon ELISA11-GLUHU-E0111-GLUHU-E012024-10-23
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISA20-TT3HU-E0120-TT3HU-E012024-07-22
B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
B24280CALPHUITCAL0Calprotectin Immunoturbidimetric Assay - Calibrators80-CALPHU-ITCAL80-CALPHU-ITCAL2023-08-18
B24280CALPHUITCON0ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-ITCON80-CALPHU-ITCON2023-08-18
B24280CALPHUIT100ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT10080-CALPHU-IT1002023-06-09

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
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