ProScreen
GUDID 00817405020836
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+MDMA+MET1000+OPI300+OXY with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 00817405020836 |
| NIH Device Record Key | 09d5e9b0-8858-481a-b76f-5ff245f8933a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProScreen |
| Version Model Number | PSDA-8MBO300 |
| 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 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| qa.portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| 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 | 00817405020836 [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 |
Trademark Results [ProScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROSCREEN 78921741 not registered Dead/Abandoned |
PROFILES INTERNATIONAL, INC. 2006-07-03 |
 PROSCREEN 78436669 3049082 Dead/Cancelled |
STEDMAN CORPORATION 2004-06-17 |
 PROSCREEN 78116161 2770361 Dead/Cancelled |
SUPERNUS PHARMACEUTICALS, INC. 2002-03-20 |
 PROSCREEN 76621760 3093738 Live/Registered |
INSTANT TECH ACQUISITION SUBSIDIARY INC. 2004-11-22 |
 PROSCREEN 76146090 not registered Dead/Abandoned |
THOMAS EQUIPMENT LTD. 2000-10-13 |
 PROSCREEN 74644155 2050214 Dead/Cancelled |
KONINKLIJKE PHILIPS ELECTRONICS N.V. 1995-03-09 |
 PROSCREEN 74501165 1934177 Dead/Cancelled |
GOLFERS 911, INC. 1994-03-15 |
 PROSCREEN 74442428 1846512 Dead/Cancelled |
Knight Manufacturing Corporation 1993-09-28 |
 PROSCREEN 73791338 1640976 Dead/Cancelled |
PROGENICS PHARMACEUTICALS, INC. 1989-04-05 |
 PROSCREEN 73307562 1213071 Dead/Cancelled |
Tetko Inc. 1981-04-27 |
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