ARK™ Gabapentin Assay 5025-0001-00

GUDID 00858724003049

The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.

ARK DIAGNOSTICS INC

Neurontin (gabapentin) IVD, reagent

• Primary Device ID: 00858724003049
• NIH Device Record Key: 57381217-c976-4cba-936e-da70dd251474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Gabapentin Assay
• Version Model Number: 5025-0001-00
• Catalog Number: 5025-0001-00
• 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	00858724003049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101574

FDA Product Code

• OTF: Gabapentin Assay

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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