FDA.reportPublic FDA data

NA

Primary DI
10815845020666
Brand
NA
Company
Alere San Diego, Inc.
Model
DOA-454
Catalog number
4012190099
Device description
One Step Drug Screen Test Card (COC300/AMP1000/mAMP1000/THC50/MOP300)
Published
2016-09-24
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
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LDJEnzyme Immunoassay, Cannabinoids
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815845020666PrimaryGS10
00815845020669Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502066610815845020666
00815845020669008158450206698158450206690815845020669

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194854949
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810124272975CERTUM One Step Multi-Line Drug Screen EZ SplitDBO-167-022-a45651613262024-10-10
00810124272982SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300)DAM-A101-a-Sgl2023-12-15
00810124272999SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000)DAM-101-a-Sgl2023-12-15
00810124273002SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)DBA-101-a-Sgl2023-12-15
00810124273019SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10)DBU-101-a-Sgl2023-12-15
00810124273026SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)DBZ-101-a-Sgl2023-12-15
00810124273033SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 150)DCO-U101-a-Sgl2023-12-15
00810124273040SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)DME-U101-a-Sgl2023-12-15
00810124273057SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500DMD-101-a-Sgl2023-12-15
00810124273064SureStepTM Urine Test Drug Screen Strip, Opiate (MOP 300)DMO-101-a-Sgl2023-12-15
00810124273071SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300)DMT-101-a-Sgl2023-12-15
00810124273088SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)DTC-101-a-Sgl2023-12-15
00810124273095SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)DTH-101-a-Sgl2023-12-15
00810124273149SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-157-01245653390192024-09-17
00810124273156SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-167-52145653490192024-09-17
00810124273163SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-02145653590192024-09-17
00810124273170SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-01145653690192024-09-17
00810124273200SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 300)DCO-101-a-Sgl2023-12-15
00810124273217SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)DME-101-a-Sgl2023-12-15
00810124273224SureStepTM Urine Test Drug Screen Strip, Opiate (OPI 2000)DMO-101-a-Sgl2023-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLFG2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644100027Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644100027Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2016-09-23
10694644100027Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644100027Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2016-09-23
10694644100027Rapid TOXAMERICAN BIO MEDICA CORPORATIONLFG2016-09-23
10694644100034Rapid TOXAMERICAN BIO MEDICA CORPORATIONLFG2016-09-23