Pancreatic Elastase Chemiluminescence ELISA

Basic Information

• Brand Name: Pancreatic Elastase Chemiluminescence ELISA
• Primary DI: B24280PANHUCH500
• Version / Model: 80-PANHU-CH50
• Catalog Number: 80-PANHU-CH50
• 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: 2022-09-09
• Public Version: 1
• Public Version Date: 2022-09-19
• Public Version Status: New
• Public Device Record Key: 4d93516f-1907-4d28-bd6e-31ba27bef871

Device Description

The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of pancreatic elastase (PE) in human stool. This assay detects both the CELA3A and CELA3B isoforms of pancreatic elastase.

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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B24280PANHUCH500	HIBCC

Customer Contacts

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

Storage Conditions

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