FDA.report

NA

Primary DI
10815845020697
Brand
NA
Company
ALERE SAN DIEGO, INC.
Model
DOA-1257-19
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

Related Records

Contact Domains

Product Codes

CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications

CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10815845020697PrimaryGS10
00815845020690Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502069710815845020697
00815845020690008158450206908158450206900815845020690

GMDN Terms

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

Contacts

PhoneEmail
(877)-441-7440xx@xx.xx

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

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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

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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
00850013035786Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
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
10815845024299SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LDJ2024-12-17
00049696712675VeriQuickFOURSTAR GROUP INC.LDJ2024-12-05
06972412611966LyherHangzhou Laihe Biotech Co.,Ltd.LDJ2024-11-12
06972412619696LyherHangzhou Laihe Biotech Co.,Ltd.LDJ2024-11-12
10810038636990Areta Multi-Drug Test Cup (25 tests kit)EASY HEALTHCARE CORPORATIONLDJ2024-09-30
40810038636434Easy@Home Multi-Drug Screen Test (5 tests kit)EASY HEALTHCARE CORPORATIONLDJ2024-07-17
00812203030773Premier BiotechCHEMTRON BIOTECH INCLDJ2024-05-28
00722066008362Rapid ResponseBTNX IncLDJ2024-02-26
00812203030681GenericCHEMTRON BIOTECH INCLDJ2024-02-05
00850040879162Number 1DEUS VULT, LLCLDJ2024-02-01
10810124273092SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)ALERE SAN DIEGO, INC.LDJ2023-12-15
10810124273337SureStepTM Urine Drug Test CassetteALERE SAN DIEGO, INC.LDJ2023-12-15
10810124273788CERTUM THC One Step Marijuana Test StripALERE SAN DIEGO, INC.LDJ2023-12-15
00850013035502Identify Health MEDICAL DISTRIBUTION GROUP INCLDJ2023-12-07
10816862023760Prime ScreenWONDFO USA CO., LTD.LDJ2023-08-03