DRI™ Fentanyl II Assay - 500mL 10028871

GUDID 00812101030769

The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.

ARK DIAGNOSTICS INC

Fentanyl IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00812101030769
• NIH Device Record Key: 5127f5b8-50e7-413a-b5e5-d3534b64c284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI™ Fentanyl II Assay - 500mL
• Version Model Number: 10028871
• Catalog Number: 10028871
• 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
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812101030769 [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: 2021-06-04
• Device Publish Date: 2021-05-27

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