DrugSmart Cup 6

GUDID 00850019007756

DrugSmart Cup 6 CLIA-Waived, THC/COC/OPI2K/MET/BZO/OXY, 25 tests/kit

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00850019007756
• NIH Device Record Key: 85e34d37-07b2-4a2c-a32e-80ca03d17215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugSmart Cup 6
• Version Model Number: C-60650D
• Company DUNS: 795658603
• Company Name: CHEMTRON BIOTECH 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019007756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142396

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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: 2017-10-13

On-Brand Devices [DrugSmart Cup 6]

• 00850019007756: DrugSmart Cup 6 CLIA-Waived, THC/COC/OPI2K/MET/BZO/OXY, 25 tests/kit
• 00850019007725: DrugSmart Cup 6, AMP/BZO/COC/MET/OPI2K/THC, 25 tests/kit