iScreen™ DOA-1114-101

GUDID 30817405022015

iScreen DOA Multi-Panel(Urine) 25T

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID30817405022015
NIH Device Record Key0fb9e562-b3a7-417e-9f8e-a27ecdc7a2f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameiScreen™
Version Model NumberDOA-1114-101
Catalog NumberDOA-1114-101
Company DUNS019410187
Company NameInstant Technologies, Inc.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817405022014 [Primary]
GS110817405022011 [Unit of Use]
GS130817405022015 [Package]
Contains: 00817405022014
Package: Master Carton [40 Units]
In Commercial Distribution

FDA Product Code

LAFGas Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-15
Device Publish Date2023-02-07

On-Brand Devices [iScreen™]

00817405021321iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/TH
00817405021314iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/TCA/TH
00817405021307iScreen™ Urine Test Drug Screen Test Card - Methamphetamine (MET)
00817405021383iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/B
10817405022219iSCREEN™ E&I Oral Fluid Test Drug Screen Swab (AMP50/COC20/MET50/OPI40/PCP10/THC40)
10817405022202iSCREEN™ E&I Oral Fluid Test Drug Screen Swab (AMP50/COC20/MET50/OPI40/PCP10)
10817405022226iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR300/
3081740502357910 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40
308174050235629 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10
308174050235557 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10/THC40
308174050235486 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10
308174050235316 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10/THC40
308174050235246 PANEL E&I OF CUBE AMP50/BAR20/COC20/OPI40/PCP10/THC40
308174050235175 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10
308174050235005 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
308174050234945 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50
3081740502348710 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, P
3081740502347010 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, P
3081740502346310 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MTD300, OPI2000,
3081740502345612 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300,
3081740502344912 PNL CLIA WVD COMP ROUND CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300,
3081740502343214 PANEL CLIA WAIVED ROUND CUP AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,PPX,TCA,THC SVT (Cr,
308174050234257 PANEL CLIA WAIVED ROUND CUP AMP1000, COC300, MET500, MOP300, OXY100, PCP25, THC50 SVT (CR, NI,
3081740502341810 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000
3081740502340114 PNL CLIA WAIVED SQUARE CUP AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MT
308174050233955 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
3081740502338812 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300,
3081740502337112 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300
3081740502336412 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300,
3081740502335711 PNL CLIA WAIVED SQUARE CUP AMP 500, BAR 300, BUP 10, BZO 300, COC 150, MDMA 500, MET 500, MO
3081740502334010 PNL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300,
308174050233337 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50
308174050233267 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MET1000, MOP300, OXY100, THC50 SVT (CR,O
308174050233194 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000
308174050232965 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR, NI, OX, pH, S.G
3081740502328910 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000
3081740502327210 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MOP300, MTD300, O
308174050232657 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,
308174050232586 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
1081740502324712 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300,
30817405021476iScreen BAR Panel(Urine) 25T
30817405021582iScreen DOA Multi-Panel(Urine) 25T
30817405021575iScreen DOA Multi-Panel(Urine) 25T
30817405021568iScreen DOA Multi-Panel(Urine) 25T
30817405021551iScreen DOA Multi-Panel(Urine) 25T
10817405022523iScreen COT Dev(Oral Fluid) 25T
30817405022503iScreen DOA Multi-Panel(Urine) 25T
30817405022497iScreen DOA Multi-Panel(Urine) 25T
30817405022480iScreen DOA Multi-Panel(Urine) 25T
30817405022473iScreen MET Panel(Urine) 25T

Trademark Results [iScreen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISCREEN
ISCREEN
88126284 not registered Live/Pending
ShenZhen Hui Tong Tian He Co., Ltd.
2018-09-21
ISCREEN
ISCREEN
86923284 5072107 Live/Registered
Hospital Central Services, Inc.
2016-02-29
ISCREEN
ISCREEN
86540757 4869695 Live/Registered
Hospital Central Services, Inc
2015-02-20
ISCREEN
ISCREEN
86540629 not registered Dead/Abandoned
Hospital Central Services, Inc
2015-02-20
ISCREEN
ISCREEN
85419056 not registered Dead/Abandoned
On Center Software, Inc.
2011-09-09
ISCREEN
ISCREEN
78693024 3290398 Dead/Cancelled
Samsung Electronics Co., Ltd.
2005-08-15
ISCREEN
ISCREEN
78470440 not registered Dead/Abandoned
Nick Payzant
2004-08-19
ISCREEN
ISCREEN
78456663 3144231 Dead/Cancelled
Samsung Electronics Co., Ltd.
2004-07-26
ISCREEN
ISCREEN
77564045 not registered Dead/Abandoned
AlphaGrip, Inc.
2008-09-07
ISCREEN
ISCREEN
77538996 3716438 Live/Registered
Instant Technologies, Inc.
2008-08-05
ISCREEN
ISCREEN
77129795 3658572 Dead/Cancelled
SecureLogic Inc.
2007-03-13
ISCREEN
ISCREEN
75693101 2622651 Live/Registered
ISCREEN VISION, INC.
1999-04-28
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.