DrugCheck 60513-6

GUDID B2986051360

DrugCheck NxStep OnSite Drug Test CLIA Waived - AMP COC MET OPI300 PCP & pH SG OX CR NI GL

Express Diagnostic Int'l, Inc.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: B2986051360
• NIH Device Record Key: 511cdc0c-e738-4446-b4d5-a54390d7a47f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugCheck
• Version Model Number: 60513-6
• Catalog Number: 60513-6
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2986051360 [Primary]

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: 2026-03-02
• Device Publish Date: 2026-02-20