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UniTest PC Skin Test System UT-400

by Lincoln Diagnostics, Inc.

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

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 Number00892093002128 UDI-DI Date12 Dec 2025ListedStatusListed GUDID: 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  • Withdrawn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
UniTest PC Skin Test System
Generic Name
Allergy testing lancet
Model / Reference
UT-400
Primary DI / UDI-DI
00892093002128
FDA Product Code
SCL
GMDN Term
Allergy testing lancet
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution

Other devices from Lincoln Diagnostics, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use

Other properties (11)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No