FDA.reportPublic FDA data

CERTUM One Step Multi-Line Drug Screen EZ Split

Primary DI
00810124272975
Brand
CERTUM One Step Multi-Line Drug Screen EZ Split
Company
Alere San Diego, Inc.
Model
DBO-167-022-a
Catalog number
4565161326
Device description
++< mAMP1000>++ +
Published
2024-10-10
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
JXMEnzyme Immunoassay, Benzodiazepine
LDJEnzyme Immunoassay, Cannabinoids

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
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810124272975PrimaryGS10
10810124272972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810124272975008101242729758101242729750810124272975
1081012427297210810124272972

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.

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
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
00810124273231SureStepTM Urine Test Drug Screen Strip, Oxycodone (OXY 100)DOX-101-a-Sgl2023-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03