ACCUTEST - 5 Drug Test Cup *CLIA-Waived*

Primary DI
10763924086532
Brand
ACCUTEST - 5 Drug Test Cup *CLIA-Waived*
Company
JANT PHARMACAL CORPORATION
Model
DS86S625
Device description
ACCUTEST - 5 Drug Test Cup *CLIA-Waived*AMP (1000), COC (300), OPI (2000), PCP (25), and THC (50)
Published
2016-09-23
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LCMEnzyme Immunoassay, Phencyclidine
LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LFHU.V. Spectrometry, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071489000HOMECHECK MULTIPLE DRUG CUP TESTTianjin New Bay Bioresearch Co., Ltd.2008-03-28DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924086532PrimaryGS10
00763924086535Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392408653210763924086532
00763924086535007639240865357639240865350763924086535

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 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. 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
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10763924601568ACCUTEST Uriscreen Rapid Screen for UTI. TestID6012016-09-24
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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
10763924319913Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3192016-09-20
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

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 CompanyLCM2026-06-03
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 CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02