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, providingan 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 applicanttracking system.
Catalog Number
2070000004
Brand Name
eREADER™
Version/Model Number
E&I V4 - New
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
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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
JJQ
Product Code Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Public Device Record Key
2ccbcbd5-df32-4f08-85ee-7cfb121ff7c6
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
April 24, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |