FDA.reportPublic FDA data

NA

Primary DI
10815845020529
Brand
NA
Company
ALERE SAN DIEGO, INC.
Model
DOA-2165
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
LDJEnzyme Immunoassay, Cannabinoids
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815845020529PrimaryGS10
00815845020522Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502052910815845020529
00815845020522008158450205228158450205220815845020522

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
80810164510736Atida Marijuana (THC) Drug of Abuse Strip Test RxACESO LABORATORIES INC.LDJ2026-03-23
10810173655931HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
10810173655955HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
M90107RD7205060QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-11
M90107RD7205030QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-10
M90107RD7205040QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-10
B2986074060DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-03-09
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
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00850013035793Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00850013035816Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00850013035823Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00812203030872DrugSmartCHEMTRON BIOTECH INCLDJ2025-09-26
00850721007334Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-09-11
00850721007204Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-09-11
10810038638093Easy@Home Marijuana Test Strip(THC 20)EASY HEALTHCARE CORPORATIONLDJ2025-07-10
10816862027324Prime ScreenWONDFO USA CO., LTD.LDJ2025-07-03
26952804810461Marijuana Test StripASSURE TECH. (HANGZHOU) CO., LTD.LDJ2025-03-18
10815845023797SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LFG2024-12-17
10815845024299SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LDJ2024-12-17