T-Cube® Tcube-10BUP

GUDID 00858945006898

T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following drugs of abuse and their principal metabolites in human oral fluid at specified cut-off levels for use in employment and insurance testing: AMP, MET, BAR, BZO, BUP, COC, OPI, OXY, THC, MDMA.

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 ID00858945006898
NIH Device Record Keya28525d9-f4cb-43de-89f4-a3ff1f387e5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Cube®
Version Model NumberTcube-10BUP
Catalog NumberTcube-10BUP
Company DUNS019410187
Company NameInstant Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Emaillisa.bates@alere.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
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 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858945006898 [Primary]

FDA Product Code

PUYTest, Barbiturate, Employment And Insurance Testing, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-02-09

On-Brand Devices [T-Cube® ]

00858945006997T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00858945006928T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00858945006911T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00858945006904T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00858945006898T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the followin
00858945006881T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00858945006874T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020997T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020980T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020966T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020959T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020942T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020935T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020928T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020577T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405020393T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following
00817405021284T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following

Trademark Results [T-Cube]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T-CUBE
T-CUBE
88095367 not registered Dead/Abandoned
Thorlabs, Inc.
2018-08-28
T-CUBE
T-CUBE
87361540 5342703 Live/Registered
Wondfo USA Co., Ltd.
2017-03-07

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