ARK™ Methotrexate Assay (c-pack) 5026-0001-01

GUDID 00858724003216

The ARK Methotrexate Assay (non c-Pack format) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.

ARK DIAGNOSTICS INC

Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00858724003216
• NIH Device Record Key: 5ce4a397-f835-4cd4-a196-0841b3821ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Methotrexate Assay (c-pack)
• Version Model Number: 5026-0001-01
• Catalog Number: 5026-0001-01
• 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	00858724003216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111904

FDA Product Code

• LAO: Enzyme Immunoassay, Methotrexate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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