Identity
- Trade Name
- eScreen eCup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The eScreen eCup® is a patented 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. FDA UDI
- Model / Reference
- eCup FDA UDI
- Description
- The eScreen eCup® is a patented 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. FDA UDI
Identifiers
- Catalog Number
- 201 FDA UDI
- Primary DI / UDI-DI
- 10867802000280 FDA UDI
- FDA Product Code
- LDJ FDA UDILCM FDA UDIDJG FDA UDIDIO FDA UDILAF FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3650 FDA UDI862.3250 FDA UDI862.3610 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
eScreen eCup by Escreen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Escreen, Inc.
Sources (1)
- FDA UDI 2ff88f09-7c04-40d3-b3de-83f36b86e363 36 fields · synced Jun 6, 2026