FDA.reportPublic FDA data

SureStep™ Urine Test Drug Screen Cassette, Barbiturates (BAR 300)

Primary DI
10810124273276
Brand
SureStep™ Urine Test Drug Screen Cassette, Barbiturates (BAR 300)
Company
ALERE SAN DIEGO, INC.
Model
DBA-102a
Published
2023-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DISEnzyme Immunoassay, Barbiturate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810124273279PrimaryGS10
10810124273276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810124273279008101242732798101242732790810124273279
1081012427327610810124273276

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194854949
Device count
40
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDIS2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2020-05-29
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDIS2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2019-02-12
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-12-05
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-07-05
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-06-20
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDIS2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDIS2018-05-21
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644500377RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-03-14