Chemcard Cholesterol

Basic Information

• Brand Name: Chemcard Cholesterol
• Primary DI: 00737051548303
• Version / Model: 43001
• Company Name: CHEMATICS, INC.
• Labeler DUNS: 196929947
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b4b86a7b-00d8-42ef-9c85-2deee67e0390

Device Description

The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
61963	Multiple lipid analyte IVD, kit, colorimetric, rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL) and low density lipoprotein (LDL)] to generate a lipid profile, within a short period of time relative to standard laboratory testing procedures, using a colorimetric method. This test is commonly used in the laboratory or in point-of-care analyses to screen patients at risk of developing coronary artery disease and/or lipid metabolism disorders. It is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00737051548327	GS1	Case	12	In Commercial Distribution
Package	00737051548310	GS1	Box	24	In Commercial Distribution
Primary	00737051548303	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K864159	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 86 Degrees Fahrenheit