FDA.reportPublic FDA data

NexScreen Drug Dip Card

Primary DI
00858984006293
Brand
NexScreen Drug Dip Card
Company
NEXSCREEN, LLC
Model
NCard-09-6AM
Catalog number
NCard-09-6AM
Device description
NexScreen Drug Dip Card 9 Panel (6AM)6AM10/AMP500/COC150/MDMA500/MET500/MOR300/OXY100/PCP25/THC50
Published
2019-12-11
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
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182123000ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.2019-03-29DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858984006293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858984006293008589840062938589840062930858984006293

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
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
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28