DrugSmart Cup 13

GUDID 00850019007626

DrugSmart Cup 13 CLIA-Waived Test, AMP/OPI300/COC/THC/MET/PCP/BAR/BZO/MTD/MDMA/OXY/TCA/BUP, 25tests/kit

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00850019007626
• NIH Device Record Key: bb533e07-63cd-4a3f-9873-826918032cf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugSmart Cup 13
• Version Model Number: C-61313D
• 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
• 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	00850019007626 [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: 2016-09-30

Devices Manufactured by CHEMTRON BIOTECH INC

• 00812203030810 - DrugSmart: 2025-10-06 DrugSmart Cup 10 CLIA-Waived THC/COC/OPI2K/OXY/AMP/MET/MTD/BZO/BUP/FYL5
• 00812203030872 - DrugSmart: 2025-10-06 DrugSmart Cup 6 AMP/COC/MET/OPI2K/PCP/THC +(Cr/SG/Ox)(Ni/pH/Gl)
• 00812203030858 - Generic: 2025-03-04 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET/MTD/MOR/OXY/PCP/THC, 25tests/kit
• 00812203030780 - DrugSmart Cup: 2024-08-06 DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2K/PCP/TCA/THC + (Cr/SG/Ox)(Ni/pH/Gl)
• 00812203030797 - Generic: 2024-08-06 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET500/MTD/MOR/OXY/PCP/THC
• 00812203030759 - Generic: 2024-06-05 TML Dip Card Test, 25pcs/kit
• 00812203030766 - Premier Biotech: 2024-06-05 10-Panel DOA Cup, AMP500/BUP/BZO/COC150/FYL5/MET500/MOR/MTD/OXY/THC, 25tests/kit
• 00812203030773 - Premier Biotech: 2024-06-05 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC, 25tests/kit