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Au B15601

by Beckman Coulter, Inc.

Au B15601 is a medical device (FDA Class I; FDA product code PPM, General Purpose Reagent) made by Beckman Coulter, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 15099590012069), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15099590012069 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Au
Generic name
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Model / reference
B15601
Primary DI / UDI-DI
15099590012069
FDA product code
PPM
GMDN term
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Optical laboratory instrument performance standard calibrator/control IVD, single-use

Similar devices in this category

Other devices filed under Optical laboratory instrument performance standard calibrator/control IVD, single-use.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)