DrugSmart Cup 8

GUDID 00850019007794

DrugSmart Cup 8, AMP/OPI2K/THC/COC/MET/BZO/MTD/OXY, CLIA-Waived, 25tests/kit

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00850019007794
• NIH Device Record Key: a8793354-19a5-4e6e-a021-41f36546b505
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugSmart Cup 8
• Version Model Number: C-60820D
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019007794 [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: 2018-02-06

Devices Manufactured by CHEMTRON BIOTECH INC

• 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
• 00812203030728 - Generic: 2024-04-17 11 Panel DOA Cup, AMP300/BZO200/BUP/COC150/MDMA/MET300/MTD/MOR/OXY/THC/FYL5/A-strips(Cr/SG/Ox)/(Ni/pH/Gl), 25tests/kit
• 00812203030711 - Generic: 2024-04-16 12-Panel DOA Dip, AMP/BZO/COC/MTD/MDMA/MET/MOR/OXY/BUP/TML/FYL5/THC
• 00812203030735 - Premier Biotech: 2024-04-16 14-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC/TML + A-strip (Ox/SG/pH), 25tests/kit