FDA.reportPublic FDA data

SAFECUP II MULTIDRUG 5

Primary DI
00695684454654
Brand
SAFECUP II MULTIDRUG 5
Company
GERMAINE LABORATORIES, INC
Model
45465
Device description
Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, mAMP, AMP, THC, OPI, (cocaine, methamphetamine, amphetamine, marijuana, opiates).
Published
2016-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LAFGas Chromatography, Methamphetamine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684454654PrimaryGS10
00695684454651Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684454654006956844546546956844546540695684454654
00695684454651006956844546516956844546510695684454651

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LAF2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LAF2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01