PTS Panels Metabolic ChemistryTest Strips (15-ct)

Basic Information

• Brand Name: PTS Panels Metabolic ChemistryTest Strips (15-ct)
• Primary DI: 00381932400015
• Version / Model: 2400
• Catalog Number: 2400
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 8
• Public Version Date: 2023-08-04
• Public Version Status: Update
• Public Device Record Key: 86a7dadd-c2cc-4609-89c7-3c6bccfe5165
• Distribution End Date: 2022-01-20

Device Description

PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monitor glucose; HDL cholesterol; and triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA 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
NGO	TEST, TRIGLYCERIDES, OVER THE COUNTER	Clinical Chemistry	862.1705	1
LBR	LDL & VLDL PRECIPITATION, HDL	Clinical Chemistry	862.1475	1
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES	Clinical Chemistry	862.1705	1
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	Clinical Chemistry	862.1345	2
NAQ	LIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER	Clinical Chemistry	862.1175	1
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52900	Multiple clinical chemistry enzyme IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes, using a spectrophotometry method. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00381932400015	GS1
Unit of Use	10381932400012	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070017	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight Keep dry
• Type: Storage Environment Temperature
• Temperature Range: 20 – 28 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 68 – 82 Degrees Fahrenheit