ARK™ Meperidine Assay 5039-0001-01

GUDID 00812101030134

The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.

ARK DIAGNOSTICS INC

Pethidine IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00812101030134
• NIH Device Record Key: acf4f504-3670-4a22-a170-7b2e04a29946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Meperidine Assay
• Version Model Number: 5039-0001-01
• Catalog Number: 5039-0001-01
• 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	00812101030134 [Primary]

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: 2019-07-30
• Device Publish Date: 2019-07-22

On-Brand Devices [ ARK™ Meperidine Assay]

• 00812101030134: The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determinati
• 00812101030127: The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determinati