DrugCheck 30110

GUDID B2983011010

Single Dip Drug Test, AMP

Express Diagnostic Int'l, Inc.

Amphetamine/methamphetamine group IVD, kit, immunochromatographic test (ICT), rapid Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

• Primary Device ID: B2983011010
• NIH Device Record Key: c2b9d36d-4aee-4f65-8477-60e7c4401ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugCheck
• Version Model Number: 30110
• Catalog Number: 30110
• Company DUNS: 015875273
• Company Name: Express Diagnostic Int'l, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2983011010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142353

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2019-04-16
• Device Publish Date: 2019-04-08