ProScreen PSCupA-10OM
GUDID 00817405020676
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00817405020676 |
| NIH Device Record Key | 4b0ec6ab-da8f-45cf-abe6-50b0fd7677b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProScreen |
| Version Model Number | PSCupA-10OM |
| Catalog Number | PSCupA-10OM |
| 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 | 00817405020676 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113046
FDA Product Code
| DKZ | Enzyme Immunoassay, Amphetamine |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.