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eScreen eReader V4

by Escreen, Inc.

eScreen eReader V4 (207 / 209) is a photometric/spectroscopic immunoassay analyser IVD (FDA Class II) made by Escreen, Inc., listed in FDA GUDID since 12 Apr 2018 (UDI-DI 00860429001008), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860429001008 UDI-DI Date12 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
eScreen eReader
Generic name
Photometric/spectroscopic immunoassay analyser IVD
Model / Ref / Catalog
V4, 207 / 209
Primary DI / UDI-DI
00860429001008
FDA product code
LDJ, LCM, DJG, DIO, LAF
GMDN term
Photometric/spectroscopic immunoassay analyser IVD
Device class
Class II
Regulation number
862.3870, 862.3650, 862.3250, 862.3610
GUDID distribution status
In Commercial Distribution

Related devices

Category: Photometric/spectroscopic immunoassay analyser IVD

Other devices from Escreen, Inc.

See all devices from Escreen, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)