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Advanced Monitor Defibrillator D100+

by Advanced Instrumentations, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB510D100 UDI-DI Date14 Jan 2026ListedStatusListed 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  • Withdrawn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
Advanced Monitor Defibrillator
Generic Name
Troponin T IVD, kit, rapid ICT, clinical
Model / Reference
D100+
Primary DI / UDI-DI
B510D100
FDA Product Code
LDD
GMDN Term
Troponin T IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
870.5300
GUDID distribution status
In Commercial Distribution

Other devices from Advanced Instrumentations, Inc.

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No