NexScreen Cup C-60505N-3A

GUDID 00858984006088

THC, COC, AMP, PCP, OPI with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)

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, 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 ID00858984006088
NIH Device Record Keye8d04bd5-fb45-45d4-9a7f-f0a83694f608
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexScreen Cup
Version Model NumberC-60505N-3A
Catalog NumberC-60505N-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 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

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
GS100858984006088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGLTest, Opiates, Over The Counter

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

On-Brand Devices [NexScreen Cup]

00858984006170AMP, BZO, COC, MET, OPI, THC drugs of abuse test cup
008589840061636000 Blank Cups BC-259 - Blank NexScreen Cup with temperature strip
00858984006149THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAI
00858984006132THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
00858984006125COC, OPI, AMP, MET, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
00858984006118OPI, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED)
00858984006101THC, COC, AMP, PCP, OPI, MET drugs of abuse test cup (CLIA WAIVED)
00858984006095THC, COC, OPI300, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
00858984006088THC, COC, AMP, PCP, OPI with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)
00858984006071THC, COC, AMP, MET, OPI with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)
00858984006064THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, TCA, OXY with adulteration OX/SG/pH drugs of ab
00858984006057THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY with adulteration OX/SG/pH drugs of abuse
00858984006040THC, COC, OPI300, AMP, MET, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup
00858984006033THC, COC, OPI, AMP, MET, PCP, BZO, BAR, MTD drugs of abuse test cup
00858984006026THC, COC, OPI, AMP, MET, PCP, MDMA drugs of abuse test cup
00858984006019THC, COC, AMP, PCP, OPI drugs of abuse test cup
00858984006002THC, COC, AMP, MET, OPI drugs of abuse test cup
00858984006279CLIA-waived NexScreen Cup 12 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/ MTD300/OPI300/OXY100/
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