PTS Panels® HDL Cholesterol Test Strips

Basic Information

• Brand Name: PTS Panels® HDL Cholesterol Test Strips
• Primary DI: 00381931714014
• Version / Model: 1714
• Catalog Number: 1714
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• 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: dca27f79-a462-4537-9b5b-52750dd0dbcf
• Distribution End Date: 2023-01-20

Device Description

PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL 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): Yes
• 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
LBR	LDL & VLDL PRECIPITATION, HDL	Clinical Chemistry	862.1475	1
NAQ	LIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER	Clinical Chemistry	862.1175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66522	High density lipoprotein (HDL) cholesterol IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of high density lipoprotein (HDL) 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 commonly used in the laboratory or in point-of-care analyses to aid in the diagnosis and/or management of cardiovascular and/or liver disease (e.g., hepatitis, cirrhosis). It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00381931714014	GS1
Unit of Use	10381931714011	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060617	000
K140068	000

Storage Conditions

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