Test-mate ChE Cholinesterase Test System

Basic Information

• Brand Name: Test-mate ChE Cholinesterase Test System
• Primary DI: 00860010612200
• Version / Model: 400
• Catalog Number: 400
• Company Name: Eqm Research, Inc.
• Labeler DUNS: 803114859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-31
• Public Version: 1
• Public Version Date: 2023-08-08
• Public Version Status: New
• Public Device Record Key: 5d349146-90cd-48bd-9769-6502916e66b2

Device Description

For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only. For use only with the AChE Assay Kit (Model 460) and the PChE Assay Kit (Model 470).

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	862.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52964	Acetylcholinesterase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme acetylcholinesterase in a clinical specimen, using a spectrophotometry method.	No	Active
36910	Photometer, absorbance/transmission, automated	An electrically-powered, automated, stand-alone laboratory instrument intended to be used to determine the absorbance or transmission of light energy transmitted through a substance, typically a solution/liquid (e.g., saliva, urine), or gas. It is used for diagnostic and/or research purposes and detects scattered light intensity, absorption and/or fluorescence.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010612200	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K961656	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius