DrugSmart Dip 30180D

GUDID 00850019007046

DrugSmart Dip 1 BUP, 25pcs/kit

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00850019007046
• NIH Device Record Key: 7f4d6d72-c4c8-4073-8381-00c8dc4d707a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugSmart Dip
• Version Model Number: 30180D
• Catalog Number: 30180D
• 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	00850019007046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142396

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2016-06-23

On-Brand Devices [DrugSmart Dip]

• 00850019007473: DrugSmart Dip 13 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/TCA/THC, 25pcs/kit
• 00850019007466: DrugSmart Dip 9 CLIA-Waived, AMP/BUP/BZO/COC/MET/MTD/OPI2000/OXY/THC, 25pcs/kit
• 00850019007442: DrugSmart Dip 1 BUP CLIA-Waived, 25pcs/kit
• 00850019007435: DrugSmart Dip 1 THC CLIA-Waived, 25pcs/kit
• 00850019007107: DrugSmart Dip 7 BUP/BZO/COC/MTD/MOR300/OXY/THC, 25pcs/kit
• 00850019007091: DrugSmart Dip 6, AMP/BAR/BZO/COC/MET/THC, 25pcs/kit
• 00850019007084: DrugSmart Dip 6, AMP/BZO/COC/MET/OPI2000/THC, 25pcs/kit
• 00850019007077: DrugSmart Dip 5, AMP/BAR/COC/OPI2000/THC ,25pcs/kit
• 00850019007060: DrugSmart Dip 5, AMP/BAR/BZO/COC/THC, 25pcs/kit
• 00850019007053: DrugSmart Dip 4, AMP/COC/MET/THC, 25pcs/kit
• 00850019007046: DrugSmart Dip 1 BUP, 25pcs/kit
• 00812203030636: DrugSmart Dip 5, AMP/COC/MET/OPI2000/THC, 25pcs/kit