PROFILE®-V MEDTOXScan®

GUDID 10690286000763

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or metabolites in human urine.

MEDTOX DIAGNOSTICS, INC.

Multiplex analyser IVD, laboratory

• Primary Device ID: 10690286000763
• NIH Device Record Key: a3ce111d-c332-40c7-b227-2a7939322d1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFILE®-V MEDTOXScan®
• Version Model Number: 604032
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690286000766 [Primary]
GS1	10690286000763 [Package]; Contains: 00690286000766; Package: kit box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080635

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [PROFILE®-V MEDTOXScan®]

• 00690286000575: Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
• 00690286000568: Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
• 10690286000053: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
• 00690286000049: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
• 10690286000039: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
• 10690286000022: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
• 00690286000018: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
• 00690286000643: Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
• 00690286000636: Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V ME
• 10690286000763: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),
• 10690286000756: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids),