PROFILE®-II

GUDID 00690286000339

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Barbiturates, and Benzodiazepines drugs and/or metabolites in human urine.

MEDTOX DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00690286000339
• NIH Device Record Key: ece3a964-e931-42c7-9117-e619fd5e4059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFILE®-II
• Version Model Number: 601607
• Company DUNS: 137417965
• Company Name: MEDTOX 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: false
• 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: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com
• Phone: 877-643-5703
• Email: techservices@medtoxdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690286000339 [Primary]
GS1	10690286000336 [Package]; Package: kit box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002331

FDA Product Code

• DIS: Enzyme Immunoassay, Barbiturate

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: 2016-09-16

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