PTS Panels® Cholesterol Test Strips

Basic Information

• Brand Name: PTS Panels® Cholesterol Test Strips
• Primary DI: 00381931790018
• Version / Model: 1790
• Catalog Number: 1790
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 5
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 82933d28-9c28-40f2-8045-cb4697730457

Device Description

PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

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: 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
NFX	TEST, CHOLESTEROL, TOTAL, OVER THE COUNTER	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
Primary	00381931790018	GS1
Unit of Use	10381931790015	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033899	000
K990688	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight Keep dry
• Type: Storage Environment Temperature
• Temperature Range: 68 – 86 Degrees Fahrenheit