ARK™ Pregabalin II Assay 5059-0001-01

GUDID 00812101031261

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

ARK DIAGNOSTICS INC

Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent Multiple anticonvulsant therapeutic drug monitoring IVD, reagent

• Primary Device ID: 00812101031261
• NIH Device Record Key: d89bcef4-18e1-463f-8a30-0241a497fc5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Pregabalin II Assay
• Version Model Number: 5059-0001-01
• Catalog Number: 5059-0001-01
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• Email: customersupport@ark-tdm.com
• Phone: 510-270-6270
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812101031261 [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: 2024-01-01
• Device Publish Date: 2023-12-22

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