Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006949423

FEI Number

3006949423

Entity Name

SYSMEX REAGENTS AMERICA, INC.

City/State/Country

Mundelein, IL, US

Establishment Address

Two Sysmex Way, Mundelein, IL 60060, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SYSMEX CORPORATION (Owner Number: 9014170)

Owner / Operator Contact Address

4-4-4 TAKATSUKADAI, NISHI-KU, KOBE, JP-NOTA 651-2271, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CELLPACK DFL Cellpack Cellsheath CELLSHEATH CCS UF-CELLSHEATH XW pack D UF-CELLPACK CR UF-CELLPACK SF Cellsheath C CELLPACK DCL UF II PACK SED UF II Sheath pocH-pack D CELLPACK S RETSEARCH II UF II PACK-BAC CELLPACK DST Lysercell WPC Lysercell WNR Lysercell WDF Sulfolyser Stromatolyser-4DS XW pack L Stromatolyser-IM Stromatolyser-4DL Stromatolyser-3WP Stromatolyser-WH Stromatolyser-NR Stromatolyser-FB pocH-pack L Stromatolyser-NR(L) Lysercell WDF II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2007-05-07
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2007-05-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SYSMEX CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1422681	SYSMEX AMERICA, INC.	Mundelein, IL, US
3009495621	Sysmex America, Inc.	Buffalo Grove, IL, US
3008526732	SYSMEX DO BRASIL IND E COM LTDA	Sao Jose dos Pinhais Parana, BR
3010188738	SYSMEX CORPORATION ONO FACTORY	Ono Hyogo, JP
3005626422	Sysmex Europe SE	Neumunster Schleswig-Holstein, DE

Similar Registrations

Registration Number	Establishment Name	Location
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
3010188738	SYSMEX CORPORATION ONO FACTORY	Ono Hyogo, JP
3000148879	HORIBA ABX SAS	MONTPELLIER Herault, FR
3009963993	AZER SCIENTIFIC, INC.	Morgantown, PA, US
3010421384	SYSMEX CORPORATION	KOBE Hyogo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006949423. Last updated year: 2026. Please use registration number 3006949423 when referencing this establishment in official correspondence.