Escreen, Inc.
Country not established
Escreen, Inc. is a medical device manufacturer, with 17 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.
- Devices
- 17
Registry facts
- Registries
- FDA GUDID 16
- FDA 510(k) 1
- Device classes
- FDA Class II 13
- FDA Class I 4
- Identifiers
- DUNS 014079359
What Escreen, Inc. makes
The company produces in-vitro diagnostic (IVD) devices for detecting multiple drugs of abuse, including rapid immunoassay kits and photometric/spectroscopic analysers. These include disposable collection cups (eCUP™, mCup®, xCup™) paired with handheld readers (eREADER™, xReader System) for point-of-care testing, as well as clinical-grade analysers for laboratory use. The portfolio also covers rapid immunoassay tests (eScreen eReader, eScreen eCup) designed for immediate results in clinical or non-clinical settings.
The devices fall under FDA-regulated Class I and Class II classifications, with some authorised through the 510(k) pathway and others listed under the Unique Device Identifier (UDI) system. The company’s products are intended for use in the United States, where they are subject to FDA oversight for compliance with diagnostic performance and safety standards.
Catalogue
Search and filter all 17 devicesCompany details
- DUNS number
- 014079359
- Phone
- 800-881-0722
Frequently asked questions
How many devices does ESCREEN, INC. have in the registry?
The registry currently lists 17 devices for ESCREEN, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ESCREEN, INC.'s devices?
Among its 17 most recently registered devices, ESCREEN, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (16 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ESCREEN, INC.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for ESCREEN, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from ESCREEN, INC. in the registry?
The most recently registered devices listed for ESCREEN, INC. include eCUP™ E&I eCUP™, eREADER™ E&I V3 - Serviced, eScreen eReader V3 and eScreen eCup.