Lipase NG

Basic Information

• Brand Name: Lipase NG
• Primary DI: 08058056681782
• Version / Model: B82715
• Catalog Number: B82715
• Company Name: SENTINEL CH. SPA
• Labeler DUNS: 429572365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 74041ecf-a0ee-448e-ae33-f3643ec90f0d

Device Description

The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.

Device Characteristics

• Single Use: No
• 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
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	862.1465	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53111	Lipase IVD, reagent	A 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 lipase in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08058056681782	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	150	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store between 2 and 8 degrees Celsius