FDA.reportPublic FDA data

Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Primary DI
10763924319913
Brand
Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Company
JANT PHARMACAL CORPORATION
Model
DS319
Device description
Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DKEReagents, Test, Tetrahydrocannabinol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924319913PrimaryGS10
00763924319916Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392431991310763924319913
00763924319916007639243199167639243199160763924319916

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid 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 cannabinoids 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. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797393659
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10763924750044Accutest H. Pylori Urease Rapid Test ID7502026-04-21
10763924601568ACCUTEST Uriscreen Rapid Screen for UTI. TestID6012016-09-24
00763924540105LipidPlus® Glucose Test StripsMD5402017-02-16
10763924532107LipidPlus® Total Cholesterol Test StripsMD5322017-02-16
10763924550507LipidPlus® MeterMD5502017-02-16
10763924851109Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)PF8512016-09-20
10763924853202Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived)PF8532016-09-20
10763924864208Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine)PF8642016-09-20
10763924320919Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3202016-09-20
10763924095213Accutest Breath Alcohol DetectorDS95AC2202016-09-24
10763924097224Accustrip Saliva Alcohol TestDS97AC1252016-09-24
10763924210142AccutestUA702A2016-09-24
10763924410146AccutestUA704A2016-09-24
10763924710147AccutestUA710A2016-09-24
10763924850508Accustrip Urine Reagent Strip ReaderUA8502016-09-24
10763924870100Accustrip 10-Parameter Urine Reagent Strip UA870007639248701032016-09-24
20763924897104Accustrip URS Strips + ReaderUA8972016-09-24
10763924309914Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3092016-09-20
10763924310910Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3102016-09-20
10763924311917Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3112016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690286000773PROFILE®-IIAMEDTOX DIAGNOSTICS, INC.DKE2023-06-01
00690286000780PROFILE-II ER®MEDTOX DIAGNOSTICS, INC.DKE2023-06-01
10796918002447Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.DKE2022-11-07
10796918002430Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2021-09-24
10796918002423INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-07-29
10796918002416INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, TALFA SCIENTIFIC DESIGNS, INC.DKE2021-07-12
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKE2021-06-24
10796918002201INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-04-21
10796918002195INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30ALFA SCIENTIFIC DESIGNS, INC.DKE2020-09-14
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2019-09-28
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-06-12
10796918002133INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-03
10796918002089INSTANT-VIEW Multi-Drugs of Abuse Urine TestALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-01
10796918002102Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-29
10796918002058INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
10796918002065INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKE2019-03-11
10796918002041INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200ALFA SCIENTIFIC DESIGNS, INC.DKE2019-02-06
10796918002010INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2018-12-14
10796918002027INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test ALFA SCIENTIFIC DESIGNS, INC.DKE2018-12-14
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-10-29
10796918001983INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, THC, XTC ALFA SCIENTIFIC DESIGNS, INC.DKE2018-08-28
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2018-04-19
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-02-16
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2017-10-12