Teco Diagnostics Glucopad Blood Glucose Test Strips

Basic Information

• Brand Name: Teco Diagnostics Glucopad Blood Glucose Test Strips
• Primary DI: 10673486000726
• Version / Model: Glucopad Blood Glucose Test Strips
• Catalog Number: G852-B-002
• Company Name: TECO DIAGNOSTICS
• Labeler DUNS: 185067774
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-19
• Public Version: 1
• Public Version Date: 2024-12-27
• Public Version Status: New
• Public Device Record Key: 57132297-3f5a-4cc6-90f6-6db64a262eda

Device Description

Teco Diagnostics Glucopad Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood (from fingertip, forearm, and palm) with the Glucopad Blood Glucose Meter. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• 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
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10673486000726	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K111456	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39.2 – 86 Degrees Fahrenheit