FDA.reportPublic FDA data

NexScreen Cup

Primary DI
00858984006279
Brand
NexScreen Cup
Company
NEXSCREEN, LLC
Model
NXS-61203N
Catalog number
NXS-61203N
Device description
CLIA-waived NexScreen Cup 12AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
Published
2019-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858984006279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858984006279008589840062798589840062790858984006279

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-956-8989info@NexScreen.com

Regulatory Flags#

DUNS number
031433133
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858984006330NexScreen Drug Screen Cup with ADNCard-12+4NCard-12+42020-10-21
00858984006347NexScreen Drug Screen CupNCard-12NCard-122020-10-21
00858984006262NexScreen Drug Screen CupND-61101Y-3AND-61101Y-3A2019-06-05
00858984006187NexScreen Drug Screen CupND-60505NND-60505N2017-11-09
00858984006194NexScreen Drug Screen CupND-60135NND-60135N2018-06-05
00858984006200NexScreen Drug Screen CupND-60610NND-60610N2018-08-30
00858984006217NexScreen Drug Screen CupND-61012NND-61012N2018-08-30
00858984006224NexScreen Drug Screen Cup with SVTND-60500N-3AND-60500N-3A2018-09-13
00858984006231NexScreen Drug Screen CupND-60511NND-60511N2018-10-05
00858984006248NexScreen Drug Screen Cup with SVTND-60505N-3AND-60505N-3A2018-10-10
00858984006255NexScreen Drug Screen CupND-60613NND-60613N2019-03-20
00858984006286NexScreen Drug Dip CardNCard-05-01NCard-05-012019-12-11
00858984006293NexScreen Drug Dip CardNCard-09-6AMNCard-09-6AM2019-12-11
00858984006309NexScreen Drug Dip CardNCard-09-01NCard-09-012019-12-11
00858984006316NexScreen Drug Dip CardNCard-12-BUPNCard-12-BUP2019-12-11
00858984006323NexScreen Drug Dip CardNCard-12-PPXNCard-12-PPX2019-12-11
00858984006002NexScreen Cup60500N60500N2016-09-01
00858984006019NexScreen Cup60505N60505N2016-09-01
00858984006026NexScreen Cup60780N60780N2016-09-01
00858984006033NexScreen Cup60925N60925N2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIS2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LAF2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LFG2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLCM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJR2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLFG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLAF2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIS2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.DIO2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIS2026-07-07
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
00841824104167ECOIIW.H.P.M. INC.LAF2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJR2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
00841824104167ECOIIW.H.P.M. INC.LCM2026-07-07
00810174471229Prime Screen®WONDFO USA CO., LTD.LCM2026-06-26