Pointe Scientific, Inc.

Basic Information

• Brand Name: Pointe Scientific, Inc.
• Primary DI: 00811727012111
• Version / Model: T7531-STD
• Catalog Number: T7531-STD
• Company Name: HORIBA INSTRUMENTS INCORPORATED
• Labeler DUNS: 052845583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2025-10-02
• Public Version Status: Update
• Public Device Record Key: 6a3ef2b5-51d9-4311-9504-1ea0dffa5c2b

Device Description

Triglyceride Standard intended for use as an triglyceride standard for standardization or calibration of enzymatic / GPO trinder triglyceride procedures. Packaged 1 x 15ml

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
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	862.1705	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44702	Triglyceride 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 triglycerides in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727012111	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K810680	000

Storage Conditions

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