iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup DUE-197-341

GUDID 10817405024077

iScreen 9 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MDMA/MTD)+(BZO/BAR)+(MET/OPI/PCP)

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10817405024077
NIH Device Record Key139536f8-3385-4b1b-bc63-7f3eb373d431
Commercial Distribution StatusIn Commercial Distribution
Brand NameiScreen™ Urine Test E-Z Split Key™ Drug Screen Cup
Version Model NumberDUE-197-341
Catalog NumberDUE-197-341
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 Perscriptionfalse
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
GS100817405024070 [Primary]
GS110817405024077 [Unit of Use]

FDA Product Code

DISEnzyme Immunoassay, Barbiturate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-24
Device Publish Date2024-07-16

On-Brand Devices [iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup]

10817405024107iScreen 8 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MET/OPI
10817405024084iScreen 10 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(AMP/C
10817405024077iScreen 9 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MDMA/MT

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

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