DrugCheck 30110C

GUDID B29830110C10

DrugCheck Single Dip Cassette Drug Test, AMP

Express Diagnostic Int'l, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: B29830110C10
• NIH Device Record Key: 047590d8-f6ae-47ee-84d7-dabc26850337
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugCheck
• Version Model Number: 30110C
• Catalog Number: 30110C
• 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: true
• 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
• 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
• 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	B29830110C10 [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: 2021-03-15
• Device Publish Date: 2021-03-05