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U-Screen USSCup-5MB

by Instant Tech Subsidiary Acquisition

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K133968; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858998006043 UDI-DI Date26 Oct 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1589-2022 FDA Class II initiated 25 May 2022 on shared 510(k) K133968

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
U-Screen
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
USSCup-5MB
Primary DI / UDI-DI
00858998006043
510(k) Number
FDA Product Code
JXM, LAF, DJG, DIO, LDJ
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3170, 862.3610, 862.3650, 862.3250, 862.3870
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K133968)

Show all (12)

Properties

  • Single Use
  • Prescription Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No