FDA.reportPublic FDA data

Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC

Primary DI
10796918001853
Brand
Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-4429
Device description
Multi-Drug of Abuse Urine Cup TestAMP COC MET MOR/OPI PCP THC
Published
2016-10-05
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
DJCThin Layer Chromatography, Methamphetamine
DKEReagents, Test, Tetrahydrocannabinol
DKZEnzyme Immunoassay, Amphetamine
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.Clinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796918001853PrimaryGS10
00796918001856Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800185310796918001853
00796918001856007969180018567969180018560796918001856

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176391167
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
20796918001904INSTANT-VIEW FOB Test - complete kit, 25 test05-7601-252019-07-01
30796918001901INSTANT-VIEW FOB Test - complete kit, 50 test05-7601-502019-07-01
10796918002157INSTANT-VIEW LH Midstream Cassette Test, 6 tests02-2540-62019-06-03
10796918002096INSTANT-VIEW FOB Test05-7602-502019-05-01
10796918001907INSTANT-VIEW FOB Test05-76022017-04-10
10796918001938INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)03-47012018-08-28
10796918001945INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)03-47022018-08-28
10796918002058INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)03-4701OT2019-03-26
10796918002065INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)03-4703OT2019-03-26
10796918002072INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)03-4705OT2019-03-26
10796918000115INSTANT-VIEW LH Ovulation Predicting Cassette Test02-25422016-09-21
10796918000122INSTANT-VIEW LH Ovulation Predicting Dip-Strip Test02-25472016-09-21
10796918000306INSTANT-VIEW Amphetamine Urine Dip-Strip Test03-30172016-09-21
10796918000368INSTANT-VIEW Methamphetamine Urine Dip-Strip Test03-30372016-09-21
10796918000429INSTANT-VIEW Cocaine (Benzoylecgonine) Urine Dip-Strip Test03-30572016-09-22
10796918000535INSTANT-VIEW Morphine/Opiates (2000) Urine Dip-Strip Test03-30972016-09-22
10796918000573INSTANT-VIEW Phencyclidine (PCP) Urine Dip-Strip Test03-31172016-09-22
10796918000603INSTANT-VIEW Benzodiazepine (BZD) Urine Dip-Strip Test03-31372016-09-22
10796918000634INSTANT-VIEW Barbiturate Urine Dip-Strip Test03-31572016-09-22
10796918000665INSTANT-VIEW Methadone Urine Dip-Strip Test03-31772016-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
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10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28