PROFILE®-V MEDTOXScan®

GUDID 00690286000568

Positive toxicology urine control used to monitor and validate the performance of PROFILE®-V MEDTOXScan® drugs of abuse test devices.

MEDTOX DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control

• Primary Device ID: 00690286000568
• NIH Device Record Key: 53e085e8-7f78-4344-8d16-0c7e7e6cf045
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFILE®-V MEDTOXScan®
• Version Model Number: 102365
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690286000568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080635

FDA Product Code

• DIF: Drug Mixture Control Materials

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

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),