Test-mate ChE Cholinesterase Test System 400

GUDID 00860010612200

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).

Eqm Research, Inc.

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• Primary Device ID: 00860010612200
• NIH Device Record Key: 5d349146-90cd-48bd-9769-6502916e66b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Test-mate ChE Cholinesterase Test System
• Version Model Number: 400
• Catalog Number: 400
• Company DUNS: 803114859
• Company Name: Eqm Research, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com
• Phone: 513-661-0560
• Email: jpe@eqmresearch.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010612200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961656

FDA Product Code

• DIH: Colorimetry, Cholinesterase

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

Devices Manufactured by Eqm Research, Inc.

• 00860010612200 - Test-mate ChE Cholinesterase Test System: 2023-08-08For 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).
• 00860010612200 - Test-mate ChE Cholinesterase Test System: 2023-08-08 For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use.
• 00860010612217 - AChE Assay Kit: 2023-08-08 For the quantitative determination of Erythrocyte Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diag
• 00860010612224 - PChE Assay Kit: 2023-08-08 For the quantitative determination of Plasma Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnosti