FDA.reportPublic FDA data

AimScreen Fentanyl

Primary DI
00695684423384
Brand
AimScreen Fentanyl
Company
GERMAINE LABORATORIES, INC
Model
42338
Published
2024-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684423384PrimaryGS10
10695684423381Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684423384006956844233846956844233840695684423384
1069568442338110695684423381

GMDN Terms#

Term, Definition table
TermDefinition
Fentanyl IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
176458115
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
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
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
00695684970321AIMSTEP PREGNANCY970322016-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJG2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-02-13
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-10-12
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-06-29
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-04-06