Escreen Inc

FDA Filings

This page includes the latest FDA filings for Escreen Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2032801
• FEI Number: 3004129879
• Name: ESCREEN, INC.
• Owner & Operator: Abbott
• Contact Address: 100 Abbott Park Building J49; Abbott Park IL 60064 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1725 W Williams Dr Bldg F67&68 ; PHOENIX, AZ 85027 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 1954435
• FEI Number: 3003110749
• Name: ESCREEN, INC.
• Owner & Operator: Abbott
• Contact Address: 100 Abbott Park Building J49; Abbott Park IL 60064 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8140 Ward Parkway Suite 300; Kansas City, MO 64114 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10867802000280 ESCREEN, INC.	eScreen eCup 201	2021-05-24
GUDID 10867802000273 ESCREEN, INC.	xCupTM DUE-1117X-071-01	2021-05-24
GUDID 10867802000266 ESCREEN, INC.	mCup®	2021-05-24
GUDID 10867802000259 ESCREEN, INC.	mCup®	2021-05-24
GUDID 10867802000242 ESCREEN, INC.	mCup®	2021-05-24
GUDID 10867802000235 ESCREEN, INC.	mCup®	2021-05-24
GUDID 10867802000228 ESCREEN, INC.	mCup®	2021-05-24
GUDID 10860429001012 ESCREEN, INC.	eCUP™ 206	2020-05-04
GUDID 00860429001053 ESCREEN, INC.	eREADER™ 2070000004	2020-05-04
GUDID 00860429001046 ESCREEN, INC.	eREADER™ 2070000003	2020-05-04
GUDID 00860429001039 ESCREEN, INC.	eREADER™ 2090000004	2020-05-04
GUDID 00860429001022 ESCREEN, INC.	eREADER™ 2090000003	2020-05-04
PVG ESCREEN, INC. [Abbott]	eCup Drugs of Abuse Screening Device	2020-04-13
PVJ ESCREEN, INC. [Abbott]	eCup Drugs of Abuse Screening Device	2020-03-03
PVJ ESCREEN, INC. [Abbott]	eCUP + Drug Screening Device	2020-03-03
PVD ESCREEN, INC. [Abbott]	eCup Drugs of Abuse Screening Device	2020-03-03
PVD ESCREEN, INC. [Abbott]	eCUP + Drug Screening Device	2020-03-03
PVD ESCREEN, INC. [Abbott]	Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay	2020-03-03
PVA ESCREEN, INC. [Abbott]	eCup Drugs of Abuse Screening Device	2020-03-03
PVA ESCREEN, INC. [Abbott]	eCUP + Drug Screening Device	2020-03-03
GUDID 10867802000211 ESCREEN, INC.	mCup®	2019-05-06
GUDID 00867802000290 ESCREEN, INC.	xReader System 301	2019-03-11
GUDID 00867802000207 ESCREEN, INC.	eScreen eReader 207 / 209	2019-03-11
GUDID 00860429001008 ESCREEN, INC.	eScreen eReader 207 / 209	2019-03-11
PMN K003352 | LDJ ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | LDJ ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | LCM ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | LCM ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | LAF ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | LAF ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | DJG ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | DJG ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | DIO ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 | DIO ESCREEN, INC. [Abbott]	eScreen Drugs of Abuse Screening Sytem	2014-12-15
PMN K003352 ESCREEN, INC.	ESCREEN SYSTEM	2001-03-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2090000004)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2090000004)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2090000003)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2090000003)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2070000004)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2070000004)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2070000003)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eReader Drug Screening Instrument (REF 2070000003)	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eREADER+ Drug Screening Instrument	1998-05-20
JJQ ESCREEN, INC. [Abbott]	eREADER+ Drug Screening Instrument	1998-05-20

Related Finance Registrations

NCAGE Code	5D2H8	ESCREEN, INC.
CAGE Code	5D2H8	ESCREEN, INC.
DUNS	014079359	ESCREEN, INC.
SEC	0001317175	ESCREEN INC of DELAWARE