FDA.reportPublic FDA data

AIMSCREEN AMP

Primary DI
00695684411251
Brand
AIMSCREEN AMP
Company
GERMAINE LABORATORIES, INC
Model
41125
Device description
Lateral flow immunoassay for the detection of Amphetamine (AMP) in urine.
Published
2016-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00695684411251PrimaryGS10
00695684411252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684411251006956844112516956844112510695684411251
00695684411252006956844112526956844112520695684411252

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
176458115
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00695684744250AimStep Flu A&B Test Kit744252026-05-11
00695684773014AimStrip Tandem Lipid Profile and glucose measuring systemILM-0001A2020-03-13
00695684775506AimStrip Tandem blood glucose test stripsILM-0001A2020-03-13
00695684773106AimStrip Tandem Total Cholesterol Test StripsILM-0001A2020-03-13
00695684773120AimStrip Tandem Total Cholesterol Control SolutionILM-0001A2020-03-13
00695684774103AimStrip Tandem Total Triglycerides Test StripsILM-0001A2020-03-13
00695684774127AimStrip Tandem Total Triglycerides Control SolutionILM-0001A2020-03-13
00695684775124AimStrip Tandem Glucose control solutionILM-0001A2020-03-13
00695684423384AimScreen Fentanyl423382024-04-01
10695684423381AimScreen Fentanyl423382024-04-01
00695684893019Pregcolor Plus893012023-08-09
00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684957018Mosie Baby Pregnancy Test957012019-10-21
00695684885304AIMSTRIP PREGNANCY885302016-04-11
00695684888305AIMSTRIP COMBO PREGNANCY888302016-04-27
00695684891015AccuHome Pregnancy Test891012016-04-11
00695684891022AccuHome Pregnancy Test891022016-04-11
00695684891404AccuHome Pregnancy Test891402016-04-11
00695684970253AIMSTEP PREGNANCY970252016-04-11
00695684970307AIMSTEP PREGNANCY970302016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.DKZ2024-02-09
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.DKZ2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.DKZ2023-11-30
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2021-06-24