FDA.reportPublic FDA data

NA

Primary DI
10815845020253
Brand
NA
Company
ALERE SAN DIEGO, INC.
Model
DMT-114
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
DJREnzyme Immunoassay, Methadone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815845020253PrimaryGS10
00815845020256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502025310815845020253
00815845020256008158450202568158450202560815845020256

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810173655580HealgenHealgen Scientific Limited Liability CompanyDJR2026-02-04
00810173654944HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
00810173654951HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
00810173655033HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
10810173655634HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-30
10810173654750Healgen Healgen Scientific Limited Liability CompanyDJR2026-01-08
10810173653999HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654569HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654613HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654668HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
00850013035991Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJR2025-12-15
00850013035731Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035762Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035779Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035847Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035861Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
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00850721007297Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-09-11
00850013035229Identify® Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2024-12-26
10815845024275SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJR2024-12-17
00812203030711GenericCHEMTRON BIOTECH INCDJR2024-04-08
10810124273078SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300)ALERE SAN DIEGO, INC.DJR2023-12-15
00850013035212Identify® Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2023-11-15
00812203030612DrugSmart Cup 10CHEMTRON BIOTECH INCDJR2023-03-23
30817405022299iScreen™Instant Technologies, Inc.DJR2023-02-07
10817405023032iCup™Instant Technologies, Inc.DJR2023-02-06
D112POLI712HP1Strauss DiamondDiamond Strauss Instruments IncDJR2022-10-14
00695684410117SAFECUP III MULTIDRUG 11GERMAINE LABORATORIES, INCDJR2022-08-17