Pointe Cholesterol Reagent

Basic Information

• Brand Name: Pointe Cholesterol Reagent
• Primary DI: 00811727016089
• Version / Model: 16-C7510-520
• Catalog Number: 16-C7510-520
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-30
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 0dfd540b-3225-4e2e-8ef0-bcdd59fc2f11

Device Description

Pointe Cholesterol Reagent packaged for use on the Mindray BA800. 8 x 65ml. For the quantitative determination of Total Cholesterol in serum.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	862.1175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53359	Total cholesterol lipid IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727016089	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K810673	000

Storage Conditions

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