FDA.reportPublic FDA data

Express ResultsTM

Primary DI
00869419000212
Brand
Express ResultsTM
Company
Quest Diagnostics
Model
UDOA-10CA-0503-01
Catalog number
DUA-1107-061-19-ONW504A
Device description
DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+ 5 MULTI-DRUG 10 PANEL UDOA-12CE-0712-01 (Previous GTIN 10869419000219)
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
DJCThin Layer Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20869419000230PrimaryGS10
00869419000212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086941900023020869419000230
00869419000212008694190002128694190002120869419000212

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
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDJC2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-05-28
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10722066005139Rapid ResponseBTNX IncDJC2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10722066005108Rapid ResponseBTNX IncDJC2020-02-12
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJC2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-07-05
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-05-23
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-02-13
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-04-06
10694644300656RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-04-06