Identity
- Trade Name
- 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
- E&I V3 - New 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
- 2070000003 FDA UDI
- Primary DI / UDI-DI
- 00860429001046 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 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
No
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
Yes
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
eREADER™ by Escreen, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Escreen, Inc.
Sources (1)
- FDA UDI 53e84699-10d7-4506-819a-7f2619204f52 36 fields · synced May 30, 2026