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Audit MicroControls Control FD Traumatic Brain Injury (TBI) K083M-8

by Aalto Scientific, Ltd.

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 NumberB085K083M80 UDI-DI Date25 Mar 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  • Withdrawn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
Audit MicroControls Control FD Traumatic Brain Injury (TBI)
Generic Name
Multiple traumatic brain injury marker IVD, control
Model / Reference
K083M-8
Primary DI / UDI-DI
B085K083M80
GMDN Term
Multiple traumatic brain injury marker IVD, control
GUDID distribution status
In Commercial Distribution

Other devices from Aalto Scientific, Ltd.

See all devices from Aalto Scientific, Ltd. →

Properties

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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