ARK™ Methotrexate Calibrator 5026-0002-00

GUDID 00858724003117

The ARK™ Methotrexate Calibrator consists of a six-level set to calibrate the ARK™ Methotrexate Assay. The calibrators consist of a synthetic protein matrix and the levels are 0.00 umol/L, 0.05 umol/L, 0.15 umol/L, 0.25 umol/L, 0.50 umol/L and 1.2 umol/L.

ARK DIAGNOSTICS INC

Methotrexate therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 00858724003117
• NIH Device Record Key: e62acc79-9c53-445c-bf59-53135677f843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Methotrexate Calibrator
• Version Model Number: 5026-0002-00
• Catalog Number: 5026-0002-00
• 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	00858724003117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111904

FDA Product Code

• DLJ: Calibrators, Drug Specific

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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