Lipase NG Cal

Basic Information

• Brand Name: Lipase NG Cal
• Primary DI: 08058056681799
• Version / Model: B83544
• Catalog Number: B83544
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a85afddc-ff90-43f1-a30f-8c5215de44ea

Device Description

Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorimetric direct determination. For In Vitro Diagnostic 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: No
• 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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53109	Lipase IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be 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	08058056681799	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033501	000

Device Sizes

Type	Value	Unit	Text
Total Volume	12	Milliliter

Storage Conditions

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