FDA.reportPublic FDA data

NexScreen Cup

Primary DI
00858984006149
Brand
NexScreen Cup
Company
NEXSCREEN, LLC
Model
C-61203N
Catalog number
C-61203N
Device description
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED)
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
LCMEnzyme Immunoassay, Phencyclidine
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082898000AMEDICA DRUG SCREEN TEST CUPAmedica Biotech, Inc.2008-12-19NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858984006149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858984006149008589840061498589840061490858984006149

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
00858984006279NexScreen CupNXS-61203NNXS-61203N2019-08-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03