FDA.reportPublic FDA data

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)

Primary DI
10766918002075
Brand
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-4705OT
Device description
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) THC
Published
2019-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10766918002075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1076691800207510766918002075

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
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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