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

Primary DI
10766918002051
Brand
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-4701OT
Device description
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) AMP BAR BUP BZD COC MET MOR MTD OXY300 PCP THC MDMA(XTC)
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
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10766918002051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1076691800205110766918002051

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

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