iScreen™ ABTDUAW113701A
GUDID 10817405023308
13 PANEL CLIA WAIVED ROUND CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 + CR, pH, S.G.
Instant Technologies, Inc.
Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 10817405023308 |
| NIH Device Record Key | 80c53d67-1021-4057-a38d-9b3f86871d4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iScreen™ |
| Version Model Number | ABTDUAW113701A |
| Catalog Number | ABTDUAW113701A |
| Company DUNS | 019410187 |
| Company Name | Instant Technologies, Inc. |
| Device Count | 25 |
| 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 | true |
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 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817405023301 [Primary] |
| GS1 | 10817405023308 [Unit of Use] |
| GS1 | 30817405023302 [Package] Contains: 00817405023301 Package: Master Carton [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182701
FDA Product Code
| NFT | Test, Amphetamine, Over The Counter |
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 | 2023-02-20 |
| Device Publish Date | 2023-02-10 |
On-Brand Devices [iScreen™]
| 00817405021321 | iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/TH |
| 00817405021314 | iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/TCA/TH |
| 00817405021307 | iScreen™ Urine Test Drug Screen Test Card - Methamphetamine (MET) |
| 00817405021383 | iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/B |
| 10817405022219 | iSCREEN™ E&I Oral Fluid Test Drug Screen Swab (AMP50/COC20/MET50/OPI40/PCP10/THC40) |
| 10817405022202 | iSCREEN™ E&I Oral Fluid Test Drug Screen Swab (AMP50/COC20/MET50/OPI40/PCP10) |
| 10817405022226 | iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR300/ |
| 30817405023579 | 10 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40 |
| 30817405023562 | 9 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10 |
| 30817405023555 | 7 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10/THC40 |
| 30817405023548 | 6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10 |
| 30817405023531 | 6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10/THC40 |
| 30817405023524 | 6 PANEL E&I OF CUBE AMP50/BAR20/COC20/OPI40/PCP10/THC40 |
| 30817405023517 | 5 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10 |
| 30817405023500 | 5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG) |
| 30817405023494 | 5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 |
| 30817405023487 | 10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, P |
| 30817405023470 | 10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, P |
| 30817405023463 | 10 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MTD300, OPI2000, |
| 30817405023456 | 12 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, |
| 30817405023449 | 12 PNL CLIA WVD COMP ROUND CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, |
| 30817405023432 | 14 PANEL CLIA WAIVED ROUND CUP AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,PPX,TCA,THC SVT (Cr, |
| 30817405023425 | 7 PANEL CLIA WAIVED ROUND CUP AMP1000, COC300, MET500, MOP300, OXY100, PCP25, THC50 SVT (CR, NI, |
| 30817405023418 | 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000 |
| 30817405023401 | 14 PNL CLIA WAIVED SQUARE CUP AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MT |
| 30817405023395 | 5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.) |
| 30817405023388 | 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, |
| 30817405023371 | 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300 |
| 30817405023364 | 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, |
| 30817405023357 | 11 PNL CLIA WAIVED SQUARE CUP AMP 500, BAR 300, BUP 10, BZO 300, COC 150, MDMA 500, MET 500, MO |
| 30817405023340 | 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, |
| 30817405023333 | 7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 |
| 30817405023326 | 7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MET1000, MOP300, OXY100, THC50 SVT (CR,O |
| 30817405023319 | 4 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000 |
| 30817405023296 | 5 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR, NI, OX, pH, S.G |
| 30817405023289 | 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000 |
| 30817405023272 | 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MOP300, MTD300, O |
| 30817405023265 | 7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX, |
| 30817405023258 | 6 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.) |
| 10817405023247 | 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, |
| 30817405021476 | iScreen BAR Panel(Urine) 25T |
| 30817405021582 | iScreen DOA Multi-Panel(Urine) 25T |
| 30817405021575 | iScreen DOA Multi-Panel(Urine) 25T |
| 30817405021568 | iScreen DOA Multi-Panel(Urine) 25T |
| 30817405021551 | iScreen DOA Multi-Panel(Urine) 25T |
| 10817405022523 | iScreen COT Dev(Oral Fluid) 25T |
| 30817405022503 | iScreen DOA Multi-Panel(Urine) 25T |
| 30817405022497 | iScreen DOA Multi-Panel(Urine) 25T |
| 30817405022480 | iScreen DOA Multi-Panel(Urine) 25T |
| 30817405022473 | iScreen MET Panel(Urine) 25T |
Trademark Results [iScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISCREEN 88126284 not registered Live/Pending |
ShenZhen Hui Tong Tian He Co., Ltd. 2018-09-21 |
 ISCREEN 86923284 5072107 Live/Registered |
Hospital Central Services, Inc. 2016-02-29 |
 ISCREEN 86540757 4869695 Live/Registered |
Hospital Central Services, Inc 2015-02-20 |
 ISCREEN 86540629 not registered Dead/Abandoned |
Hospital Central Services, Inc 2015-02-20 |
 ISCREEN 85419056 not registered Dead/Abandoned |
On Center Software, Inc. 2011-09-09 |
 ISCREEN 78693024 3290398 Dead/Cancelled |
Samsung Electronics Co., Ltd. 2005-08-15 |
 ISCREEN 78470440 not registered Dead/Abandoned |
Nick Payzant 2004-08-19 |
 ISCREEN 78456663 3144231 Dead/Cancelled |
Samsung Electronics Co., Ltd. 2004-07-26 |
 ISCREEN 77564045 not registered Dead/Abandoned |
AlphaGrip, Inc. 2008-09-07 |
 ISCREEN 77538996 3716438 Live/Registered |
Instant Technologies, Inc. 2008-08-05 |
 ISCREEN 77129795 3658572 Dead/Cancelled |
SecureLogic Inc. 2007-03-13 |
 ISCREEN 75693101 2622651 Live/Registered |
ISCREEN VISION, INC. 1999-04-28 |
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