FDA.reportPublic FDA data

INSTANT-VIEW Amphetamine Urine Dip-Strip Test

Primary DI
10796918000306
Brand
INSTANT-VIEW Amphetamine Urine Dip-Strip Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-3017
Device description
INSTANT-VIEW Amphetamine Urine Dip-Strip 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
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796918000306PrimaryGS10
00796918000309Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800030610796918000306
00796918000309007969180003097969180003090796918000309

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine-specific 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 a specific amphetamine 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
50
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
Primary DIBrandCompanyProduct codePublished
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B2987050460DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-20
B298307220DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
B298605010DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
10810173655665HealgenHealgen Scientific Limited Liability CompanyDKZ2026-01-30
B298606220DrugCheck Express Diagnostic Int'l, Inc.DKZ2025-12-09
00841824105706N/AW.H.P.M. INC.DKZ2025-12-04
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00858886006841Noble Drug Test Cup (Urine)NOBLE MEDICAL INCDKZ2025-01-17
10815845024381SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DKZ2024-12-17
10810124273160SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273177SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273658SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273665SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
00841824105553ECOIIW.H.P.M. INC.DKZ2024-08-22
00841824104730EZ CLICKW.H.P.M. INC.DKZ2024-07-25
10840050517496Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DKZ2024-05-23
10840050517526Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DKZ2024-05-23
10816862024286T-DipWONDFO USA CO., LTD.DKZ2024-05-17
20817038022249inSight 12 Panel Drug Test CupUCP BIOSCIENCES, INC.DKZ2024-05-16
00841824105492ECOIIW.H.P.M. INC.DKZ2024-04-26
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