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ProScreen PSDA-8MBO300

by Instant Tech Subsidiary Acquisition

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

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 Number00858998006388 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ProScreen
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
PSDA-8MBO300
Primary DI / UDI-DI
00858998006388
FDA Product Code
DJG, DJC, JXM, DKZ, LDJ, DIO
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3650, 862.3610, 862.3170, 862.3100, 862.3870, 862.3250
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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