At Home Drug Test for Methamphetamine

GUDID 00674033090682

Urine based drug testing device for Methamphetamine

PHAMATECH, INCORPORATED

Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical

• Primary Device ID: 00674033090682
• NIH Device Record Key: e25bf51c-ea40-4100-a274-df4ab36857f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: At Home Drug Test for Methamphetamine
• Version Model Number: 9068T
• Company DUNS: 947803078
• Company Name: PHAMATECH, INCORPORATED
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com
• Phone: 877-466-3837
• Email: athomedrugtest@phamatech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00674033090682 [Primary]

FDA Product Code

• MVO: Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-02

Devices Manufactured by PHAMATECH, INCORPORATED

• 00674033090682 - At Home Drug Test for Methamphetamine: 2018-03-29Urine based drug testing device for Methamphetamine
• 00674033090682 - At Home Drug Test for Methamphetamine: 2018-03-29 Urine based drug testing device for Methamphetamine
• 00674033090736 - At Home Single Panel COC + Timer: 2018-03-29 Single Panel Cocaine urine drug test device with Timer
• 00674033090781 - At Home Drug Test for Marijuana: 2018-03-29 Urine based drug of abuse test for THC