ALPCO Pancreatic Elastase CLIA

Basic Information

• Brand Name: ALPCO Pancreatic Elastase CLIA
• Primary DI: B24280PANHUFC1000
• Version / Model: 80-PANHU-FC100
• Catalog Number: 80-PANHU-FC100
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-25
• Public Version: 2
• Public Version Date: 2024-11-07
• Public Version Status: Update
• Public Device Record Key: 903fe5a6-8bc0-4762-98fb-c0d1eb83f398

Device Description

The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for the quantitative measurement of fecal pancreatic elastase (PE) in human stool. The Pancreatic Elastase CLIA kit is intended for in vitro diagnostic use as an aid in the diagnosis and treatment of pancreatic disease, including exocrine pancreatic insufficiency (EPI), in conjunction with other clinical and laboratory findings. The test is specifically designed for use with the KleeYa platform. For In Vitro Diagnostic Use in the United States.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
53142	Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)	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 an enzyme immunoassay (EIA) 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	B24280PANHUFC1000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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