Identity
- Trade Name
- eScreen eReader FDA UDI
- Generic Name
- Photometric/spectroscopic immunoassay analyser IVD FDA UDI
- Device Name
- The eScreen eReader is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providing an automated, objective, confidential testing process. The eReader uses bar code technology, coupled with optical imaging, to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes, the eReader automatically reports a negative eCup urine drug screen back to you via your account or another applicant tracking system. FDA UDI
- Model / Reference
- V3 FDA UDI
- Description
- The eScreen eReader is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providing an automated, objective, confidential testing process. The eReader uses bar code technology, coupled with optical imaging, to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes, the eReader automatically reports a negative eCup urine drug screen back to you via your account or another applicant tracking system. FDA UDI
Identifiers
- Catalog Number
- 207 / 209 FDA UDI
- Primary DI / UDI-DI
- 00867802000207 FDA UDI
- FDA Product Code
- LDJ FDA UDILCM FDA UDIDJG FDA UDIDIO FDA UDILAF FDA UDI
- GMDN Term
- Photometric/spectroscopic immunoassay analyser IVD 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Photometric/spectroscopic immunoassay analyser IVD
eScreen eReader 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 adb1cc0c-4957-4dad-be6b-fb4c06545533 36 fields · synced May 30, 2026