DrugSmart

GUDID 00812203030810

DrugSmart Cup 10 CLIA-Waived THC/COC/OPI2K/OXY/AMP/MET/MTD/BZO/BUP/FYL5

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00812203030810
• NIH Device Record Key: 5b6ec3c1-1f33-4d27-bc26-2d1403c6abd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugSmart
• Version Model Number: 61080D
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812203030810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232736

FDA Product Code

• LAF: Gas Chromatography, Methamphetamine

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: 2025-10-06
• Device Publish Date: 2025-09-26

On-Brand Devices [DrugSmart]

• 00812203030872: DrugSmart Cup 6 AMP/COC/MET/OPI2K/PCP/THC +(Cr/SG/Ox)(Ni/pH/Gl)
• 00812203030810: DrugSmart Cup 10 CLIA-Waived THC/COC/OPI2K/OXY/AMP/MET/MTD/BZO/BUP/FYL5