FDA.reportPublic FDA data

NA

Primary DI
10815845021052
Brand
NA
Company
ALERE SAN DIEGO, INC.
Model
DOA-144-991
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
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815845021052PrimaryGS10
00815845021055Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502105210815845021052
00815845021055008158450210558158450210550815845021055

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
10810173655931HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
10810173655955HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
10810173655047HealgenHealgen Scientific Limited Liability CompanyLFG2026-02-04
10810173655689HealgenHealgen Scientific Limited Liability CompanyLFG2026-02-04
10810173655610HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655672Healgen Healgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655696HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655702HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655719HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
00810173654937HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-08
10810173654521Healgen Healgen Scientific Limited Liability CompanyLFG2025-12-19
10810173654545HealgenHealgen Scientific Limited Liability CompanyLFG2025-12-19
10810173654651HealgenHealgen Scientific Limited Liability CompanyLFG2025-12-19
10815845023797SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LFG2024-12-17
10810124273085SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)ALERE SAN DIEGO, INC.LFG2023-12-15
00690286000780PROFILE-II ER®MEDTOX DIAGNOSTICS, INC.LFG2023-06-01
30817405022442iScreen™Instant Technologies, Inc.LFG2023-02-07
00869419000243Express ResultsTM Quest DiagnosticsLFG2022-03-28
20612479255306McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
20612479255337McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
20612479258444McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10816862021780PreviewWONDFO USA CO., LTD.LFG2019-12-22
20817038021631UCP Home Drug Screening Test CupsUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021730UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021778UCP Drug Test Mini Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021815u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021860u-Cup Drug Test ScreenUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021891UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
00895330002790Healgen (Private Label) - 3124CONFIRM BIOSCIENCES, INC.LFG2016-11-15
20817038021136u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2016-10-24