ARK™ Hydrocodone Control 5076-0003-00

GUDID 00812101031124

The ARK™ Hydrocodone Control is intended for use in quality control of the ARK™ Hydrocodone Assay.

ARK DIAGNOSTICS INC

Pethidine IVD, control

• Primary Device ID: 00812101031124
• NIH Device Record Key: 6aebc525-9611-4bbf-99bc-1075da3ed7a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Hydrocodone Control
• Version Model Number: 5076-0003-00
• Catalog Number: 5076-0003-00
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812101031124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231752

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2024-10-24
• Device Publish Date: 2024-10-16

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• 00812101031056 - DRI Tramadol Control Kit: 2024-11-22 Tramadol Control Kit - Thermo
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