DrugSmart Cup C61213D

GUDID 00850019007503

DrugSmart Cup 12, THC/COC/MOR300/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY, 25pcs/kit

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00850019007503
• NIH Device Record Key: 0cac9424-bf04-4754-ad21-f74ebdfcc1d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugSmart Cup
• Version Model Number: C61213D
• Catalog Number: C61213D
• 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	00850019007503 [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: 2016-06-27

On-Brand Devices [DrugSmart Cup]

• 00850019007640: DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2000/PCP/TCA/THC, 25 tests/kit
• 00850019007589: DrugSmart Cup 9, AMP/BAR/BZO/COC/MTD/OPI2K/PCP/PPX/THC, 25tests/kit
• 00850019007503: DrugSmart Cup 12, THC/COC/MOR300/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY, 25pcs/kit
• 00850019007497: DrugSmart Cup 9, THC/COC/MOR300/AMP/MET/BZO/MTD/BUP/OXY, 25pcs/kit
• 00850019007480: DrugSmart Cup 6, AMP/COC/THC/OPI2000/MET/OXY, 25pcs/kit
• 00850019007138: DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI2000/TCA/THC, 25pcs/kit
• 00850019007121: DrugSmart Cup 6, AMP/COC/THC/OPI/MET/OXY, 25pcs/kit
• 00850019007114: DrugSmart Cup 5, AMP/COC/MET/OPI/THC, 25pcs/kit
• 00812203030698: DrugSmart Cup 4, AMP/COC/MET/OPI2K, 25 tests/kit
• 00812203030780: DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2K/PCP/TCA/THC + (Cr/SG/Ox)(Ni/pH/Gl)