FDA.reportPublic FDA data

NA

Primary DI
10815845020765
Brand
NA
Company
ALERE SAN DIEGO, INC.
Model
DOA-21107-19
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815845020765PrimaryGS10
00815845020768Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502076510815845020765
00815845020768008158450207688158450207680815845020768

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
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
false
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
00899722002337Alere Cholestech LDX®99020990202016-06-29
10810124273832CERTUM One Step Multi-Drug Screen PanelDOA-164-141-a45665913262024-12-17
10810124273849CERTUM One Step Multi-Drug Screen PanelDOA-154-061-a45666013262024-12-17
10810124273856CERTUM One Step Multi-Drug Screen PanelDOA-154-201-a45666113262024-12-17
10810124273863CERTUM One Step Multi-Drug Screen PanelDOA-134-011-a45666213262024-12-17
10810124273870CERTUM One Step Multi-Drug Screen PanelDOA-124-031-a45666313262024-12-17
10815845023148SureStep™ Urine Test Drug Screen StripDCO-10145605590022024-12-17
10815845023155SureStep™ Urine Test Drug Screen StripDBA-10145605690022024-12-17
10815845023162SureStep™ Urine Test Drug Screen StripDPC-10145605790022024-12-17
10815845023797SureStep™ Urine Test Drug Screen StripDTC-10145609790022024-12-17
10815845024220SureStep™ Urine Test Drug Screen StripDMD-10145610190022024-12-17
10815845024237SureStep™ Urine Test Drug Screen StripDMO-10145610290022024-12-17
10815845024268SureStep™ Urine Test Drug Screen StripDOX-10145610590022024-12-17
10815845024275SureStep™ Urine Test Drug Screen StripDMT-10145610690022024-12-17
10815845024299SureStep™ Urine Test Drug Screen StripDTH-10145610890022024-12-17
10815845024305SureStep™ Urine Test Drug Screen StripDBZ-10145611090022024-12-17
10815845024381SureStep™ Urine Test Drug Screen StripDAM-10145611790022024-12-17
10815845024398SureStep™ Urine Test Drug Screen StripDOP-10145611890022024-12-17
10815845024404SureStep™ Urine Test Drug Screen StripDME-10145611990022024-12-17
10810124272972CERTUM One Step Multi-Line Drug Screen EZ SplitDBO-167-022-a45651613262024-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173655927HealgenHealgen Scientific Limited Liability CompanyDIO2026-03-11
10810173656006HealgenHealgen Scientific Limited Liability CompanyDIO2026-03-11
10810173656013HealgenHealgen Scientific Limited Liability CompanyDIO2026-03-11
10810173655573HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-30
10810173655733HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-30
00810173654784HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-08
10810173655092HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-08
10810173654590HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
10810173654606HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
10810173654620HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
00850013035755Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDIO2025-12-04
00850013035854Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDIO2025-12-04
00850721007679Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDIO2025-09-11
10810124273832CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10810124273849CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10810124273856CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10810124273863CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10810124273870CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIO2024-12-17
10815845023148SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DIO2024-12-17
00850013036004Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2024-11-20
06972412618569LyherHangzhou Laihe Biotech Co.,Ltd.DIO2024-11-12
10810124272972CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273795CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273801CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273818CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273825CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124274518CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273146SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DIO2024-09-17
10810124273566SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DIO2024-09-17
10810124273573SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DIO2024-09-17