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mCup® MCP5-001

by Escreen, Inc.

mCup MCP5-001, a multiple drugs of abuse IVD (FDA Class II) made by Escreen, Inc., was listed in FDA GUDID on 24 Sep 2016 (UDI-DI 10867802000211); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10867802000211 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
mCup®
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / reference
MCP5-001
Primary DI / UDI-DI
10867802000211
FDA product code
LDJ, LCM, LAF, DKZ, DJG, DIO
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3870, 862.3610, 862.3100, 862.3650, 862.3250
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LDJ (Enzyme Immunoassay, Cannabinoids).

Other devices from Escreen, Inc.

See all devices from Escreen, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)