FDA.reportPublic FDA data

eScreen eReader

Primary DI
00860429001008
Brand
eScreen eReader
Company
ESCREEN, INC.
Model
V4
Catalog number
207 / 209
Device 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.
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860429001008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860429001008008604290010088604290010080860429001008

GMDN Terms#

Term, Definition table
TermDefinition
Photometric immunoassay analyser IVDA portable, electrically-powered instrument, intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument uses photometry to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by health professionals for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-881-0722clientservice@escreen.com

Regulatory Flags#

DUNS number
014079359
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10867802000228mCup®MCP7A-001 2016-09-24
10867802000235mCup®MCP9A-0012016-09-24
10867802000242mCup®MCP10A-0012016-09-24
10867802000259mCup®MCP11A-0012016-09-24
10867802000266mCup®MCP5A-0012016-09-24
10867802000273xCupTMDUE-1117X-071-01DUE-1117X-071-012016-09-24
10867802000280eScreen eCupeCup2012016-09-16
10860429001012eCUP™E&I eCUP™2062020-04-24
10867802000211mCup®MCP5-0012016-09-24
00860429001022eREADER™E&I V3 - Serviced20900000032020-04-24
00860429001039eREADER™E&I V4 - Serviced20900000042020-04-24
00860429001046eREADER™E&I V3 - New20700000032020-04-24
00860429001053eREADER™E&I V4 - New20700000042020-04-24
00867802000207eScreen eReaderV3207 / 2092016-08-26
00867802000290xReader SystemBS-0610S3012016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLAF2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLCM2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28