Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

Beckman Coulter Mishima K.K.

JAPAN

9612296

2026

analyzer, chemistry (photometric, discrete), for clinical use - DxC 500 AU Clinical Chemistry Analyzer

Contract Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - AU Beckman Coulter Chemistry Analyzers; Beckman Coulter Chemistry Analyzer AU480

Contract Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - Beckman Coulter Chemistry Analyzer AU680

Contract Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - Beckman Coulter Chemistry Analyzer AU5800

Contract Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - B86443 DxC 700 AU; B86444 DxC 700 AU with ISE; B86445 DxC 700 AU for Direct Track Sampling; B86446 DxC 700 AU for Direct Track Sampling with ISE

Contract Manufacturer

Show all 6 Listings for Beckman Coulter Mishima K.K. JAPAN

BECKMAN COULTER, INC.

CA/USA

2050010

2026

analyzer, chemistry (photometric, discrete), for clinical use - 442765 Albumin Reagent (ALB 2 x 300); 442820 Urea Reagent (UREA 2 x 300); 475106 Prealbumin Reagent (PAB 2 x 100)

Contract Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - BUN Electrode; Calcium Electrode; Chloride Electrode; CO2 Electrode; Glucose Oxygen Sensor; NA+ Electrode; Potassium Electrode; SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2

Contract Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - 467858 SYNCHRON Systems Albumin Reagent; Calcium Electrode; Chloride Electrode; CO2 Electrode; NA+ Electrode; Potassium Electrode; SYNCHRON Systems Glucose Reagent (Glucose Oxidase) SYNCHRON Systems CO2 Alkaline Buffer; SYNCHRON Systems Phosphorus Reagent SYNCHRON Systems CO2 Acid Reagent SYNCHRON Systems Urea Nitrogen (BUN) Reagent; Synchron Systems Total Protein Reagent; UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon

Contract Manufacturer

BECKMAN COULTER, INC.

CA/USA

2050012

2026

analyzer, chemistry (photometric, discrete), for clinical use - A27318 Unicel DxC 600i Synchron Access Clinical System; A59102 Unicel DxC 880i Synchron Access Clinical System; A64868 Unicel DxC 660i Synchron Access Clinical System; A64869 Unicel DxC 680i Synchron Access Clinical System; A64870 Unicel DxC 860i Synchron Access Clinical System; A64871 UniCel DxC 660i - Full System Domestic; A64872 UniCel DxC 660i - Full System; A64903 UniCel DxC 680i - Full System Domestic; A64904 UniCel DxC 680i - Full System; A64935 UniCel DxC 860i - Full System Domestic; A64936 UniCel DxC 860i - Full System; SYNCHRON UniCel DxC 600i, 800i, 660i, 860i

Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - A15445 IMMAGE 800

Specification Developer

analyzer, chemistry (photometric, discrete), for clinical use - 467858 SYNCHRON Systems Albumin Reagent; Calcium Electrode; Chloride Electrode; CO2 Electrode; NA+ Electrode; Potassium Electrode; SYNCHRON Systems Glucose Reagent (Glucose Oxidase) SYNCHRON Systems CO2 Alkaline Buffer; SYNCHRON Systems Phosphorus Reagent SYNCHRON Systems CO2 Acid Reagent SYNCHRON Systems Urea Nitrogen (BUN) Reagent; Synchron Systems Total Protein Reagent; UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon

Manufacturer; Specification Developer

analyzer, chemistry (photometric, discrete), for clinical use - BUN Electrode; Calcium Electrode; Chloride Electrode; CO2 Electrode; Glucose Oxygen Sensor; NA+ Electrode; Potassium Electrode; SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2

Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - 442765 Albumin Reagent (ALB 2 x 300); 442820 Urea Reagent (UREA 2 x 300); 475106 Prealbumin Reagent (PAB 2 x 100)

Specification Developer

BECKMAN COULTER, INC.

MN/USA

2122870

2026

analyzer, chemistry (photometric, discrete), for clinical use - Access 2 Immunoassay System (P/N: 81600N); Access AccuTnI +3 Calibrators for use on the Access 2 Immunoassay System (P/N A98144); Access AccuTnI +3 for Use on the Access 2 Immunoassay System (P/N: A98143)

Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - Access TSH (3rd IS) (P/N: B63284 MN and IE MFG); Access TSH (3rd IS) (P/N: C28643 MN MFG); DxI 9000 Immunoassay Analyzer (P/N: C11137)

Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - Access AccuTnI +3 Calibrators for use on the UniCel DxI Immunoassay Systems.(P/N: A98265); Access AccuTnI +3 for use on the UniCel DxI Immunoassay Systems. (P/N: A98264); UniCel DxI 600 Access Immunoassay System (P/N: A30260); UniCel DxI 600 Access Immunoassay System w/ Dual Gantry (P/N: A71461); UniCel DxI 600 Access Immunoassay System w/ Spot B Gantry (P/N: A71460); UniCel DxI 800 Access Immunoassay System (P/N: 973100); UniCel DxI 800 Access Immunoassay System w/ Dual Gantry (P/N: A71457); UniCel DxI 800 Access Immunoassay System w/ Spot B Gantry (P/N: A71456)

Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - UniCel DxI 800 Access Immunoassay System (P/N: 973100)

Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, C13252 (Chaska MFG); DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63521 (JPN MFG); DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63522 (JPN MFG)

Manufacturer

Show all 6 Listings for BECKMAN COULTER, INC. MN/USA

BEIJING HOTGEN BIOTECH CO., LTD.

CHINA

3017894300

2026

analyzer, chemistry (photometric, discrete), for clinical use - Automatic Chemiluminescence Immunoassay Analyzer

Manufacturer

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Establishment Registration & Device Listing

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