FDA.reportPublic FDA data

ECOII

Primary DI
00841824105560
Brand
ECOII
Company
W.H.P.M. INC.
Model
ECOII-07144
Catalog number
ECOII-07144
Device description
DOA 14 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/PPX/TCA/THC
Published
2024-08-22
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
DISEnzyme Immunoassay, Barbiturate
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
JXNEnzyme Immunoassay, Propoxyphene
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
MTDCatheter, Intracardiac Mapping, High-Density Array

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
MTDCatheter, Intracardiac Mapping, High-Density ArrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824105560PrimaryGS10
00841824105553Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824105560008418241055608418241055600841824105560
00841824105553008418241055538418241055530841824105553

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
00841824104167ECOIIECOII-4104 W/AD6ECOII-4104 W/AD62026-07-07
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
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
00817405024247iScreen™Instant Technologies, Inc.JXN2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIS2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LAF2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLCM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLAF2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXN2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIS2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.LAF2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIO2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIS2026-07-07
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.LCM2026-07-07
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
00810174471229Prime Screen®WONDFO USA CO., LTD.LCM2026-06-26
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25