FDA.reportPublic FDA data

DRI Tricyclics Serum Tox Assay

Primary DI
00884883001183
Brand
DRI Tricyclics Serum Tox Assay
Company
Microgenics Corporation
Model
1128
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFHU.V. Spectrometry, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883001183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883001183008848830011838848830011830884883001183

GMDN Terms#

Term, Definition table
TermDefinition
Tricyclic antidepressant IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884883009080MAS Immunology Advanced Sample PackICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1ICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2ICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3ICA-3032026-05-27
00884883011427CRP (C-Reactive Protein)75-54422026-05-27
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414595849TD TRICYC ANTIDEPRESSANT ASSAY, TCASiemens Healthcare Diagnostics Inc.LFH2018-12-01
00868348000256Status Toxi CupLifesign L.L.C.LFH2017-05-17
10868348000253Status Toxi CupLifesign L.L.C.LFH2017-05-17
00816565020960Fastect II Drug Screen Dipstick TestAMEDITECH INC.LFH2017-03-31
00748349000311QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-27
00748349000274QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-24
00748349000243QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-12-13
00748349000199QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
20748349000193QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
00748349000175QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
20748349000179QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
00748349000106QuikScreen Multi 11 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-04
00748349000113QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-10-04
20748349000117QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-10-04
10864040000331QTEST 11 (25 pack)MEDIMPEX UNITED, INCLFH2016-09-30
10864040000348QTEST 12 (25 Pack)MEDIMPEX UNITED, INCLFH2016-09-30
00863480002106LifeSign QuikScreen 11Lifesign L.L.C.LFH2016-09-24
00863480002113Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00842768001277Syva® RapidTest d.a.u.® TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
20863480002117Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00630414551036ADVIA® Chemistry TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
10763924086532ACCUTEST - 5 Drug Test Cup *CLIA-Waived*JANT PHARMACAL CORPORATIONLFH2016-09-23
10763924087539ACCUTEST - 6 Drug CupJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924811530ACCUTEST Drug Test Cup 11-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924822536ACCUTEST Drug Test Cup 12-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924823533ACCUTEST Drug Test Cup 13-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
00817405020010Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020027Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020126Alere iScreen DxInstant Technologies, Inc.LFH2016-09-19
00817405020171Alere iScreen DxInstant Technologies, Inc.LFH2016-09-19