I-SAT Cup 61101Y-3A

GUDID 00858984006156

THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY with adulteration OX/SG/pH drugs of abuse test cup

NEXSCREEN, LLC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00858984006156
NIH Device Record Key62aa508a-5e69-4a4d-817e-981cae331dbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-SAT Cup
Version Model Number61101Y-3A
Catalog Number61101Y-3A
Company DUNS031433133
Company NameNEXSCREEN, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.com
Phone1-888-956-8989
Emailinfo@NexScreen.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
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858984006156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

Devices Manufactured by NEXSCREEN, LLC

00858984006330 - NexScreen Drug Screen Cup with AD2020-10-29 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)
00858984006347 - NexScreen Drug Screen Cup2020-10-29 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
00858984006286 - NexScreen Drug Dip Card2019-12-19 NexScreen Drug Dip Card 5 Panel COC150/THC50/AMP500/OPI2000/PCP25
00858984006293 - NexScreen Drug Dip Card2019-12-19 NexScreen Drug Dip Card 9 Panel (6AM) 6AM10/AMP500/COC150/MDMA500/MET500/ MOR300/OXY100/PCP25/THC50
00858984006309 - NexScreen Drug Dip Card2019-12-19 NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
00858984006316 - NexScreen Drug Dip Card2019-12-19 NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
00858984006323 - NexScreen Drug Dip Card2019-12-19 NexScreen Drug Dip Card 12 Panel (PPX) BZO300/BAR300/COC150/THC50/MET500/OPI2000/ MTD300/OXY100/MDMA500/PCP25/AMP500/PPX300
00858984006279 - NexScreen Cup2019-09-09 CLIA-waived NexScreen Cup 12 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/ MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
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