ARK™ Levetiracetam II Control 5070-0003-00

GUDID 00812101030660

ARK Levetiracetam II Control is intended for use in quality control of the ARK Levetiracetam II Assay.

ARK DIAGNOSTICS INC

Levetiracetam therapeutic drug monitoring IVD, control

• Primary Device ID: 00812101030660
• NIH Device Record Key: 04637c63-31bb-4b98-a6e1-54a6903a5d6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Levetiracetam II Control
• Version Model Number: 5070-0003-00
• Catalog Number: 5070-0003-00
• 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: false
• 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
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812101030660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232522

FDA Product Code

• ORI: Levetiracetam Assay

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: 2024-11-01
• Device Publish Date: 2024-10-24

Devices Manufactured by ARK DIAGNOSTICS INC

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• 00812101031018 - DRI Tramadol Assay - 115mL: 2024-11-22 Tramadol Assay - 115 mL Thermo
• 00812101031025 - DRI Tramadol Negative Calibrator Kit: 2024-11-22 Tramadol Negative Calibrator Kit - Thermo
• 00812101031032 - DRI Tramadol Cutoff Calibrator Kit: 2024-11-22 Tramadol Cutoff Calibrator Kit - Thermo
• 00812101031049 - DRI Tramadol Calibrator Kit: 2024-11-22 Tramadol Calibrator Kit - Thermo
• 00812101031056 - DRI Tramadol Control Kit: 2024-11-22 Tramadol Control Kit - Thermo
• 00812101031469 - ARK Levetiracetam II Assay: 2024-11-04 The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam
• 00812101030646 - ARK™ Levetiracetam II Assay: 2024-11-01 The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam