FDA.reportPublic FDA data

DrugSmart Dip

Primary DI
00859144006283
Brand
DrugSmart Dip
Company
Twin Spirit Inc.
Model
30510D
Catalog number
30510D
Device description
AMP/BAR/BZO/COC/THC DipCard
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113046000AMEDITECH IMMUTEST MILTI-DRUG SCREENAmeditech, Inc.2011-11-10DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859144006283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859144006283008591440062838591440062830859144006283

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
1-760-494-7502info@nativediagnostics.com

Regulatory Flags#

DUNS number
617011296
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
00859144006009DrugSmart CupC-60650DC-60650D2016-09-01
00859144006016DrugSmart CupC-60820DC-60820D2016-09-01
00859144006023DrugSmart CupC-60823DC-60823D2016-09-01
00859144006030DrugSmart CupC-61026DC-61026D2016-09-01
00859144006047DrugSmart CupC-61103DC-61103D2016-09-01
00859144006054DrugSmart CupC-61203DC-61203D2016-09-01
00859144006061DrugSmart Cup61210D61210D2016-09-01
00859144006078DrugSmart Cup61205D61205D2016-09-01
00859144006085DrugSmart Cup61085D61085D2016-09-01
00859144006092DrugSmart Cup61055D61055D2016-09-01
00859144006108DrugSmart Cup61050D61050D2016-09-01
00859144006115DrugSmart Cup61025D61025D2016-09-01
00859144006122DrugSmart Cup61023D61023D2016-09-01
00859144006139DrugSmart Cup61020D61020D2016-09-01
00859144006146DrugSmart Cup61015D61015D2016-09-01
00859144006153DrugSmart Cup60960D60960D2016-09-01
00859144006160DrugSmart Cup60620D60620D2016-09-01
00859144006177DrugSmart Cup60600D60600D2016-09-01
00859144006184DrugSmart Cup60560D60560D2016-09-01
00859144006191DrugSmart Cup60505D60505D2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIS2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31