FDA.reportPublic FDA data

Express ResultsTM

Primary DI
00869419000243
Brand
Express ResultsTM
Company
Quest Diagnostics
Model
DOA-154-181
Catalog number
DOA-154-ONC62B
Device description
DOA-154-181(COC/AMP/THC/OPI/PCP)MULTI-DRUG 5 PANEL SCREEN TEST (DOA-154-181) previous (GTIN 10869419000240)
Published
2022-03-28
Public version status
New
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
20869419000247PrimaryGS10
00869419000243Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086941900024720869419000247
00869419000243008694190002438694190002430869419000243

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
189222334
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
00850054552136K-QUE-ACT-001-PRK-QUE-ACT-001-PR2026-05-01
00850054552068K-QUE-ACT-001 REV002K-QUE-ACT-001 REV0022026-02-25
00850054552075K-QUE-ACT-003 REV002K-QUE-ACT-003 REV0022026-02-25
00850054552082K-QUE-ACT-004 REV002K-QUE-ACT-004 REV0022026-02-25
00850054552099K-QUE-ACT-005 REV002K-QUE-ACT-005 REV0022026-02-25
00850054552105K-QUE-ACT-006 REV001K-QUE-ACT-006 REV0012026-02-25
00850054552112K-QUE-ACT-007 REV000K-QUE-ACT-007 REV0002026-02-25
00850054552129K-QUE-KED-001 REV000K-QUE-KED-001 REV0002026-02-25
00850054552037US Blood And Urine KitExempt2024-05-01
00810121520000Blood Specimen Collection Kit (EPH)Exempt2023-08-23
00868586000247HairCheck-DT (THC)K0402572016-09-23
10869419000219Express ResultsTMUDOA-10CA-0503-01 2016-09-24
00850054552044US Paramed Collection Oral Fluid KitExempt2024-05-01
00850054552051US Urine Examiner KitExempt2024-05-01
10850054552034US Blood And Urine KitExempt2024-05-01
10850054552041US Paramed Collection Oral Fluid KitExempt2024-05-01
10850054552058US Urine Examiner KitExempt2024-05-01
00868586000292Quest Diagnostics Oral Fluid Oxycodone HEIAPVH-Exempt2017-10-02
00850054552013US Agent Collection Oral Fluid KitExempt2024-01-15
10869419000202Express ResultsTM UDOA-6CA-0503-012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLFG2026-06-02
10850013035523Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035585Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035608Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850076289062Hysen Drug Test CupsHYSEN INC.LFG2026-03-18
10850076289000Hysen Drug Test CupsHYSEN INC.LFG2025-08-04
10850076289017Hysen Drug Test CardsHYSEN INC.LFG2025-08-04
10858886006848Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2025-01-17
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LFG2024-02-09
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LFG2023-11-30
10858886006824Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2023-10-20
10817038022174Number OneUCP BIOSCIENCES, INC.LFG2023-06-16
10850013035189Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2023-03-08
10858886006770Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2023-02-14
10796918002447Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.LFG2022-11-07
10850013035172Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2022-08-01
10858886006701Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-07-14
10858886006688Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-06-14
10858886006565Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006572Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006596Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
20869419000230Express ResultsTM Quest DiagnosticsLFG2022-03-28
20869419000247Express ResultsTM Quest DiagnosticsLFG2022-03-28