NexScreen Drug Screen Cup with AD NCard-12+4

GUDID 00858984006330

AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)

NEXSCREEN, LLC

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 ID00858984006330
NIH Device Record Key22c4b259-35d8-4326-8fc5-d17836fce8a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexScreen Drug Screen Cup with AD
Version Model NumberNCard-12+4
Catalog NumberNCard-12+4
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 Kitfalse
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-Countertrue

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858984006330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-29
Device Publish Date2020-10-21

Devices Manufactured by NEXSCREEN, LLC

00858984006330 - NexScreen Drug Screen Cup with AD2020-10-29AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)
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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