Chemcard Glucose

Basic Information

• Brand Name: Chemcard Glucose
• Primary DI: 00737051736908
• Version / Model: 47000
• 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: 1e9f85e4-81dd-4dbb-9781-1df1d861f9ac

Device Description

The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma glucose concentration which can be a sign of diabetes or other medical problems. The Chemcard™ Glucose Test provides a preliminary, semi-quantitative result using fingerstick blood as the test specimen. 510K Cleared - CliaWaived

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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53304	Glucose IVD, kit, colorimetric dipstick, rapid	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00737051736922	GS1	Case	12	In Commercial Distribution
Package	00737051736915	GS1	Box	24	In Commercial Distribution
Primary	00737051736908	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K943503	000

Storage Conditions

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