eREADER™ - The eScreen eREADER™ is a sophisticated appliance - ESCREEN, INC.

Duns Number:014079359

Device Description: The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the 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.

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More Product Details

Catalog Number

2090000003

Brand Name

eREADER™

Version/Model Number

E&I V3 - Serviced

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJQ

Product Code Name

Colorimeter, Photometer, Spectrophotometer For Clinical Use

Device Record Status

Public Device Record Key

2239558a-d18e-4054-b9c6-251961dba3b3

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

April 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ESCREEN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 2