ARK™ Pregabalin II Assay 5059-0001-00

GUDID 00812101030448

The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of pregabalin in human urine at a cutoff concentration of 500 ng/mL.

ARK DIAGNOSTICS INC

Multiple anticonvulsant therapeutic drug monitoring IVD, reagent

• Primary Device ID: 00812101030448
• NIH Device Record Key: f20bcd44-550a-4917-9ae9-4923f72c5c16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Pregabalin II Assay
• Version Model Number: 5059-0001-00
• Catalog Number: 5059-0001-00
• 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	00812101030448 [Primary]

FDA Product Code

• NWM: Immunoassay, Anti-Seizure Drug

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: 2019-07-11
• Device Publish Date: 2019-07-03

On-Brand Devices [ARK™ Pregabalin II Assay]

• 00812101030448: The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and/or semiquantit
• 00812101031261: The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and /or semi-quant