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Diagnostix™ 5120NLBD

by American Diagnostic Corporation

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00634782086725 UDI-DI Date15 May 2019ListedStatusListed 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  • Withdrawn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
Diagnostix™
Generic Name
Ophthalmic/otologic diagnostic set
Model / Ref / Catalog
5120NLBD
Primary DI / UDI-DI
00634782086725
FDA Product Code
ERA
GMDN Term
Ophthalmic/otologic diagnostic set
Device Class
Class I
Regulation Number
874.4770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic/otologic diagnostic set

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No