CHORUS CLIA FECAL ELASTASE

Basic Information

• Brand Name: CHORUS CLIA FECAL ELASTASE
• Primary DI: 08033891328474
• Version / Model: 82304
• Catalog Number: 82304
• Company Name: DIESSE DIAGNOSTICA SENESE SPA
• Labeler DUNS: 435036669
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-01
• Public Version: 1
• Public Version Date: 2025-07-09
• Public Version Status: New
• Public Device Record Key: e395a6a5-2c00-48ba-ac47-aa31d4efb724

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JNN	P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin	Clinical Chemistry	862.1725	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67387	Pancreatic elastase (PE) IVD, kit, chemiluminescent immunoassay	A 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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033891328474	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius