SYSMEX REAGENTS AMERICA, INC.

Contract manufacturer · Mundelein, IL

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration

3006949423 (openFDA record; or search FDA's registration database)

FEI number

3006949423

Registered for

FDA registration year 2027

Establishment types

Contract manufacturer

Owner or operator

SYSMEX CORPORATION (FDA owner/operator no. 9014170)

Registered address

Two Sysmex Way, Mundelein, IL 60060

Contract listings

2 device listings, 2 product codes, first listed May 7, 2007

Certification

Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.