Skip to content

Audit MicroControls Linearity FD Urine Chemistry for Beckman AU K829M-10

by Aalto Scientific, Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB085K829M100 UDI-DIDate20 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Audit MicroControls Linearity FD Urine Chemistry for Beckman AU
Generic Name
Multiple urine analyte IVD, control
Model / Reference
K829M-10
Primary DI / UDI-DI
B085K829M100
GMDN Term
Multiple urine analyte 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