ARK™ Topiramate Assay 5015-0001-00

GUDID 00858724003001

The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.

ARK DIAGNOSTICS INC

Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00858724003001
• NIH Device Record Key: b55eccb4-73c6-46d9-8162-8fdfa169b3c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Topiramate Assay
• Version Model Number: 5015-0001-00
• Catalog Number: 5015-0001-00
• 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	00858724003001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083799

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

Devices Manufactured by ARK DIAGNOSTICS INC

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• 00812101030523 - ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator: 2021-09-08 ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Ass
• 00812101030530 - ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator: 2021-09-08 ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Ass