SYSMEX CORPORATION

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• sysmex.com

Registered Device Listings#

Product Codes Associated With Registrations#

GUDID#

• Automated Hematology Analyzer XE-2100D - 03309313

  SYSMEX CORPORATION

  2019-02-07

• Automated Hematology Analyzer XS series XS-1000i - Sysmex XS-1000i™ Automated Hematology Analyzer

  SYSMEX CORPORATION

  2016-08-04

• Fully Automated Urine Particle Analyzer UF-1000i - Sysmex UF-1000i™ Automated Urine Particle Analyzer

  SYSMEX CORPORATION

  2016-08-04

• Automated Hematology Analyzer XS series XS-1000iC - XS-1000iC Complete

  SYSMEX CORPORATION

  2016-08-05

• UF ll CALIBRATOR - 06404310

  SYSMEX CORPORATION

  2017-10-06

• CA CAL S - The product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.

  SYSMEX CORPORATION

  2024-02-22

• CA CAL S - CA CAL S 3.0X3 (GCL-100A)

  SYSMEX CORPORATION

  2017-10-06

• LYSERCELL WDF II - Lysing reagent for hematology analyzers

  SYSMEX CORPORATION

  2026-04-24

• UF II CONTROL - UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device.

  SYSMEX CORPORATION

  2022-11-30

• Automated Blood Coagulation Analyzer CN-3000 - The CN-Series (CN-3000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations.

  SYSMEX CORPORATION

  2025-12-19

• Automated Blood Coagulation Analyzer CN-3000 - The CN-Series (CN-3000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations.

  SYSMEX CORPORATION

  2025-12-19

• EIGHTCHECK-3WP - EightCheck-3WP X-tra 4X2MLX3 Lo/Norm/Hi

  SYSMEX CORPORATION

  2016-08-05

• RANGE CHECK X lll - Range Check X lll 24X3.0ML WBC/RBC/PLT

  SYSMEX CORPORATION

  2016-08-05

• plt-CHECK - plt-CHECK Level 1-12X4.5ML

  SYSMEX CORPORATION

  2017-10-06

• plt-CHECK - plt-CHECK Level 2- 12X4.5ML

  SYSMEX CORPORATION

  2017-10-06

• Automated Blood Coagulation Analyzer CS-5100 - A fully automated blood coagulation analyzer intended for in vitro diagnostic use.

  SYSMEX CORPORATION

  2024-02-22

• Automated Blood Coagulation Analyzer CS-2500 - A fully automated blood coagulation analyzer intended for in vitro diagnostic use.

  SYSMEX CORPORATION

  2024-02-22

• Automated Blood Coagulation Analyzer CA-600 series CA-620 - A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use

  SYSMEX CORPORATION

  2024-02-22

• Automated Blood Coagulation Analyzer CA-600 series CA-660 - a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use.

  SYSMEX CORPORATION

  2024-02-22

• Automated Blood Coagulation Analyzer CS-5100 - CS-5100 COMPLETE

  SYSMEX CORPORATION

  2016-08-05

• Automated Blood Coagulation Analyzer CA-600 series CA-620 - Automated Blood Coagulation Analyzer CA-620

  SYSMEX CORPORATION

  2016-08-04

• Automated Blood Coagulation Analyzer CA-600 series CA-660 - Automated Blood Coagulation Analyzer CA-660

  SYSMEX CORPORATION

  2016-08-05

• Automated Blood Coagulation Analyzer CS-2500 - CS-2500 COMPLETE

  SYSMEX CORPORATION

  2016-09-16

• Automated Blood Coagulation Analyzer CN-6000 - The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations.

  SYSMEX CORPORATION

  2025-08-22

• Automated Blood Coagulation Analyzer CN-6000 - The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations.

  SYSMEX CORPORATION

  2025-08-22

• UDM (Urinalysis Data Manager) - 1.X

  SYSMEX CORPORATION

  2025-03-14

• XQ-520 XQ-Series Automated Hematology Analyzer - The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-520 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#

  SYSMEX CORPORATION

  2025-01-14

• XQ-320 XQ-Series Automated Hematology Analyzer - The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, R DW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

  SYSMEX CORPORATION

  2024-05-24

• Automated Hematology Analyzer pocH-100i - pocH-100i (US)

  SYSMEX CORPORATION

  2016-08-04

• Automated Hematology Analyzer XN series XN-10 - XN-10 Complete

  SYSMEX CORPORATION

  2016-08-04

• Automated Hematology Analyzer XN series XN-20 - AE797961

  SYSMEX CORPORATION

  2018-10-15

• Automated Hematology Analyzer XP series XP-300 - Automated Hematology Analyzer XP-300

  SYSMEX CORPORATION

  2016-08-04

• Automated Hematology Analyzer XN series XN-11 - XN-11 Complete

  SYSMEX CORPORATION

  2016-08-03

• Automated Hematology Analyzer XN-L series XN-330 - CX851950

  SYSMEX CORPORATION

  2017-06-05

• Automated Hematology Analyzer XN-L series XN-350 - AW618382

  SYSMEX CORPORATION

  2017-02-20

• Automated Hematology Analyzer XN-L series XN-430 - CL032175

  SYSMEX CORPORATION

  2017-06-05

• Automated Hematology Analyzer XN-L series XN-450 - BM392756

  SYSMEX CORPORATION

  2017-02-20

• Automated Hematology Analyzer XN-L series XN-530 - BQ391107

  SYSMEX CORPORATION

  2017-06-05

• Automated Hematology Analyzer XN-L series XN-550 - BD634545

  SYSMEX CORPORATION

  2017-02-20

• Automated Hematology Analyzer XW-100 - CT129514

  SYSMEX CORPORATION

  2018-02-13

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