FDA.reportPublic FDA data

INSTANT-VIEW TCA Urine Dip Cassette Test

Primary DI
10796918000252
Brand
INSTANT-VIEW TCA Urine Dip Cassette Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-2972QW
Device description
INSTANT-VIEW TCA Urine Dip Cassette Test
Published
2016-09-21
Public version status
Update
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
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
10796918000252PrimaryGS10
00796918000255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800025210796918000252
00796918000255007969180002557969180002550796918000255

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
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
00796918002440Multi-Drug of Abuse Urine Cup Test03-46802022-11-07
00796918002433Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THC03-44392021-09-24
00796918002426INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR30003-39482021-07-29
00796918002419INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, T03-3803QW2021-07-12
00796918002204INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR30003-39422021-04-21
00796918002198INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR3003-39452020-09-14
20796918001904INSTANT-VIEW FOB Test - complete kit, 25 test05-7601-252019-07-01
30796918001901INSTANT-VIEW FOB Test - complete kit, 50 test05-7601-502019-07-01
10796918002096INSTANT-VIEW FOB Test05-7602-502019-05-01
10796918001778INSTANT-VIEW FOB Test05-76022016-09-23
10796918001785INSTANT-VIEW FOB Test05-7602-22016-09-23
10796918001907INSTANT-VIEW FOB Test05-76022017-04-10
10796918001914Instant-view plus Immunochemical Fecal Occult Blood Test05-76322018-08-28
10796918001921Instant-view plus Immunochemical Fecal Occult Blood Test05-7632OT2018-08-28
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THC03-35512019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THC03-34622019-06-12
10796918002157INSTANT-VIEW LH Midstream Cassette Test, 6 tests02-2540-62019-06-03
10796918002164INSTANT-VIEW FSH Midstream Cassette Test02-25602019-06-03
10796918002140 Instant-View HCG Midstream Cassette, 2t02-2480-22019-05-30
10796918002119INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test03-3072OT-52019-05-03

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Primary DI, Brand, Company table
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10810124273085SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)ALERE SAN DIEGO, INC.LFG2023-12-15
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20612479255306McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
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20612479258444McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10816862021780PreviewWONDFO USA CO., LTD.LFG2019-12-22
20817038021631UCP Home Drug Screening Test CupsUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021730UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021778UCP Drug Test Mini Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021815u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021860u-Cup Drug Test ScreenUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021891UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
00895330002790Healgen (Private Label) - 3124CONFIRM BIOSCIENCES, INC.LFG2016-11-15
20817038021136u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2016-10-24