FDA.reportPublic FDA data

NA

Primary DI
10815845020475
Brand
NA
Company
Alere San Diego, Inc.
Model
DOA-1125
Catalog number
4011840099
Device description
CLIA-WAIVED One Step Multi-Drug, Multi-Line Screen Test Device (COC300/THC50)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815845020475PrimaryGS10
00815845020478Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502047510815845020475
00815845020478008158450204788158450204780815845020478

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

Contacts#

Phone, Email table
PhoneEmail
(858) 535-2030xx@xx.xx

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.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-09-28
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-12
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-30
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2017-10-12
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2017-06-29
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2017-06-08
10694644200437RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-10-10
10694644200420RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-10-04
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644200024RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644200031RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644200048RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644200055RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-09-23