Cholesterol

Basic Information

• Brand Name: Cholesterol
• Primary DI: 00381934770017
• Version / Model: REF 4770
• Catalog Number: 4770
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-06-16
• Public Version: 1
• Public Version Date: 2025-06-24
• Public Version Status: New
• Public Device Record Key: 537371bb-c0c7-480d-a944-ec471655a70e

Device Description

PTS Panels® cholesterol self-test strips are for the quantitative measurement of total cholesterol in capillary whole blood from the fingertip. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This system is intended for self-testing use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
65746	Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative measurement of total cholesterol lipid in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10381934770014	GS1
Primary	00381934770017	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K990688	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius