ARK™ Zonisamide Assay 5022-0001-00

GUDID 00858724003018

The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The ARK™ Zonisamide Assay consists of reagents RI anti-zonisamide polyclonal antibody with substrate and R2 zonisamide epitope labeled with bacterial G6PDH enzyme.

ARK DIAGNOSTICS INC

Zonisamide therapeutic drug monitoring IVD, reagent

• Primary Device ID: 00858724003018
• NIH Device Record Key: 7beb2126-43ec-4871-96ef-6013baf6c82e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Zonisamide Assay
• Version Model Number: 5022-0001-00
• Catalog Number: 5022-0001-00
• Company DUNS: 164880598
• Company Name: ARK DIAGNOSTICS 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5102706270
• Email: customersupport@ark-tdm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858724003018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091884

FDA Product Code

• NWM: Immunoassay, Anti-Seizure Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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