PROFILE®-V MEDTOXScan®

GUDID 00690286000575

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

• Primary Device ID: 00690286000575
• NIH Device Record Key: b0dd35f5-962b-47ca-853f-ebe81a0a6174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFILE®-V MEDTOXScan®
• Version Model Number: 102367
• 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	00690286000575 [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),