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Icon 395160

by Beckman Coulter, Inc.

Icon 395160 is a Class I device made by Beckman Coulter, Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 15099590625924), 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 Number15099590625924 UDI-DI Date23 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  • Withdrawn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
Icon
Generic name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
395160
Primary DI / UDI-DI
15099590625924
FDA product code
LYR
GMDN term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Device class
Class I
Regulation number
866.3110
GUDID distribution status
In Commercial Distribution

Related devices

Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.

Other devices from Beckman Coulter, Inc.

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)