T-Cup® Compact ACDOA-6125

GUDID 00817504020560

T-Cup® Compact Multi-Drug Urine Test Cup

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817504020560
NIH Device Record Keyaa292052-cf0c-43d6-bb88-a8bf5ae462a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Cup® Compact
Version Model NumberACDOA-6125
Catalog NumberACDOA-6125
Company DUNS019410187
Company NameInstant Technologies, Inc.
Device Count1
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@alere.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817504020560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-01
Device Publish Date2019-04-23

On-Brand Devices [T-Cup® Compact ]

00817504020560T-Cup® Compact Multi-Drug Urine Test Cup
00817405021048T-Cup® Compact Multi-Drug Urine Test Cup
00817405021031T-Cup® Compact Multi-Drug Urine Test Cup
00817405021024T-Cup® Compact Multi-Drug Urine Test Cup
00817405021017T-Cup® Compact Multi-Drug Urine Test Cup
00817405021000T-Cup® Compact Multi-Drug Urine Test Cup
00817405020560T-Cup® Compact Multi-Drug Urine Test Cup
10817405021298UScreen Squared Integrated CLIA Waived Cup with Adulterants (CR/NI/pH/OX/SG) 14 Panel Drug Scree

Trademark Results [T-Cup]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T-CUP
T-CUP
87151774 5212506 Live/Registered
Wondfo USA Co., Ltd.
2016-08-26
T-CUP
T-CUP
86362305 not registered Dead/Abandoned
Minnesota Medtech
2014-08-10

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