ProScreen

GUDID 00817405020737

Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY

Instant Technologies, Inc.

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

• Primary Device ID: 00817405020737
• NIH Device Record Key: 19f6e6a9-bc8d-47e5-9056-f0c6c84a7a2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProScreen
• Version Model Number: PSD-6MTDBO300
• Company DUNS: 019410187
• Company Name: Instant Technologies, 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: false
• Manufacturing Date: false
• 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: false

Customer Support Contacts

• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: qa.portsmouth@abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405020737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113046

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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: 2019-10-22
• Device Publish Date: 2019-10-14

On-Brand Devices [ProScreen]

• 00817405020904: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD+PPX with Cr, Ni, pH,
• 00817405020898: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni,
• 00817405020881: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
• 00817405020850: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+BZO+OPI300 with C
• 00817405020836: Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+MDMA+MET1000+OPI300+OXY with Cr, Ni, pH, Bl, S.G.
• 00817405020812: Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC with Cr, Ni, pH, Bl, S.G.
• 00817405020805: Drugs of Abuse Test Card, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, S.G.
• 00817405020775: Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
• 00817405020768: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+MTD+PPX
• 00817405020751: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+BUP+MTD
• 00817405020744: Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
• 00817405020737: Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
• 00817405020720: Drugs of Abuse Test Card, (MET1000/OPI2000)+BZO+COC+OXY+THC
• 00817405020713: Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BZO+COC+THC
• 00817405020706: Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC
• 00817405020690: Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC
• 00817405020676: Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl
• 00817405020652: Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
• 00817405020621: Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G.
• 00817405020614: Drugs of Abuse Cup, CLIA Waived, AMP/BZO/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
• 00817405020591: Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
• 00817405020584: Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC