FDA.reportPublic FDA data

INSTANT-VIEW TCA Urine Cassette Test

Primary DI
10796918000245
Brand
INSTANT-VIEW TCA Urine Cassette Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-2972
Device description
INSTANT-VIEW TCA Urine Cassette Test
Published
2016-09-21
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
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796918000245PrimaryGS10
00796918000248Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800024510796918000245
00796918000248007969180002487969180002480796918000248

GMDN Terms#

Term, Definition table
TermDefinition
Tricyclic antidepressant IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs 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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10850076289062Hysen Drug Test CupsHYSEN INC.LFG2026-03-18
10850076289000Hysen Drug Test CupsHYSEN INC.LFG2025-08-04
10850076289017Hysen Drug Test CardsHYSEN INC.LFG2025-08-04
10858886006848Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2025-01-17
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16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LFG2023-11-30
10858886006824Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2023-10-20
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10858886006688Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-06-14
10858886006565Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2022-04-28
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10858886006596Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
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