Home GUDID 10860429001012
eCUP™
Primary DI 10860429001012
Brand eCUP™
Company ESCREEN, INC.
Model E&I eCUP™
Catalog number 206
Device description The eScreen eCUP™ is a patented human urine collection device designed to allow for rapid, under-seal screening. The eCUP™’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCUP™ is placed into the eREADER™ device, its test strips are digitally screened for the presence or absence of drugs of abuse.
Published 2020-04-24
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 Code Name PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt PVG Test, Morphine, Employment And Insurance Testing, Exempt PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology 2 PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology 2 PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology 2 PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860429001012 Primary GS1 0 00860429001015 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860429001012 10860429001012 00860429001015 00860429001015 860429001015 0860429001015
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 014079359 Device count 50 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G474M310601EI0 mLife Classic Mlife Diagnostics, LLC PVA 2026-04-29 G474M310601EI0 mLife Classic Mlife Diagnostics, LLC PVJ 2026-04-29 G474M310601EI0 mLife Classic Mlife Diagnostics, LLC PVD 2026-04-29 G474M321002EI0 mLife Verify Mlife Diagnostics, LLC PVA 2026-04-29 G474M321002EI0 mLife Verify Mlife Diagnostics, LLC PVJ 2026-04-29 G474M321002EI0 mLife Verify Mlife Diagnostics, LLC PVD 2026-04-29 G474M310501EI0 mLife Classic Mlife Diagnostics, LLC PVD 2026-04-03 G474M310501EI0 mLife Classic Mlife Diagnostics, LLC PVA 2026-04-03 B29880913EI0 DrugCheck Express Diagnostic Int'l, Inc. PVA 2026-02-23 B29880913EI0 DrugCheck Express Diagnostic Int'l, Inc. PVD 2026-02-23 B29880502EI0 DrugCheck Express Diagnostic Int'l, Inc. PVD 2026-02-20 B29880502EI0 DrugCheck Express Diagnostic Int'l, Inc. PVJ 2026-02-20 B29880502EI0 DrugCheck Express Diagnostic Int'l, Inc. PVA 2026-02-20 G474M321001EI0 mLife Verify Mlife Diagnostics, LLC PVJ 2026-01-29 G474M321001EI0 mLife Verify Mlife Diagnostics, LLC PVD 2026-01-29 G474M321001EI0 mLife Verify Mlife Diagnostics, LLC PVA 2026-01-29 00810174470963 PRIME SCREEN® WONDFO USA CO., LTD. PVJ 2025-12-05 00810174470963 PRIME SCREEN® WONDFO USA CO., LTD. PVD 2025-12-05 00810174470963 PRIME SCREEN® WONDFO USA CO., LTD. PVA 2025-12-05 00810174471007 PRIME SCREEN® WONDFO USA CO., LTD. PVD 2025-12-05 00810174471007 PRIME SCREEN® WONDFO USA CO., LTD. PVJ 2025-12-05 00810174471007 PRIME SCREEN® WONDFO USA CO., LTD. PVA 2025-12-05 00810174471144 PRIME SCREEN® WONDFO USA CO., LTD. PVA 2025-12-03 00810174471144 PRIME SCREEN® WONDFO USA CO., LTD. PVD 2025-12-03 00810174471144 PRIME SCREEN® WONDFO USA CO., LTD. PVJ 2025-12-03 00810174471168 PRIME SCREEN® WONDFO USA CO., LTD. PVJ 2025-12-03 G474M3209010 Verify Mlife Diagnostics, LLC PVJ 2025-09-05 G474M3209010 Verify Mlife Diagnostics, LLC PVA 2025-09-05 G474M3209010 Verify Mlife Diagnostics, LLC PVD 2025-09-05 G474M3208010 Verify Mlife Diagnostics, LLC PVA 2025-07-21