Skip to content

Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)

by Tyson Bioresearch Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number04719869706959 UDI-DI Date13 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Glucose IVD, control
Model / Reference
Tyson Bio AC500 PRO
Primary DI / UDI-DI
04719869706959
510(k) Number
FDA Product Code
NBW, CGA
GMDN Term
Glucose IVD, control
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K123087)

Show all (12)

Other devices from Tyson Bioresearch Inc.

See all devices from Tyson Bioresearch Inc. →

Properties

  • Single Use
  • Prescription Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No