FDA.reportPublic FDA data

ECOII

Primary DI
00841824105355
Brand
ECOII
Company
W.H.P.M. INC.
Model
ECOII-83104
Catalog number
ECOII-83104
Device description
DOA 10 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BUP/BZO/COC/EDDP/mAMP/MTD/OPI/OXY/THC
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LAFGas Chromatography, Methamphetamine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824105355PrimaryGS10
00841824105348Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824105355008418241053558418241053550841824105355
00841824105348008418241053488418241053480841824105348

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA 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 [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
602085672
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841824105577ECOIIECOII-6664ECOII-66642026-03-19
00841824101845ECOIIECOII-6664ECOII-66642026-03-19
00811925030009ADS MedicalT1-CK30-ADSM2018-03-29
00811925030023ADS MedicalT1-CK30T-ADSM2018-03-29
00811925030030ADS MedicalT1-CK50-ADSM2018-03-29
00811925030047ADS MedicalT1-CT30-ADSM2018-03-29
00811925030054ADS MedicalT1-CT50-ADSM2018-03-29
00811925030061ADS MedicalT1-TB30-ADSM2018-03-29
00811925030078ADS MedicalT1-TB50-ADSM2018-03-29
00841824105706N/AW944W9442025-12-04
00841824105690EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105683EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105652N/AWMA500-25WMA500-252025-06-13
00841824105645N/AWMA500-25WMA500-252025-06-13
00841824105560ECOIIECOII-07144ECOII-071442024-08-22
00841824105553ECOIIECOII-07144ECOII-071442024-08-22
10841824104737EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824104730EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824105416N/AW4374W43742024-06-14
00841824105409N/AW4374W43742024-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2016-09-23
10694644100027Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2016-09-23
10694644100027Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2016-09-23