BECKMAN COULTER, INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• Access AFP Reagents on the Access Immunoassay Systems

  2020-12-16

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2020-12-16

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassay Systems

  2020-12-16

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2020-12-16

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassay System

  2020-10-16

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2020-10-16

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassay Systems

  2020-10-16

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2020-10-16

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassay Systems

  2020-10-07

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2020-10-07

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassay Systems

  2020-10-07

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2020-10-07

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassay Systems

  2020-03-17

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2020-03-17

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassay Systems

  2020-03-17

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2020-03-17

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassay Systems

  2019-08-09

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2019-08-09

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassay Systems

  2019-08-09

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2019-08-09

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2019-07-31

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassay Systems

  2019-07-31

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassay Systems

  2019-07-31

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2019-07-31

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagent Pack

  2019-01-09

  BECKMAN COULTER, INC.

• Acess AFP Reagents on the Access Immunoassay Systems

  2018-12-21

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2018-12-21

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassay Systems

  2018-12-21

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2018-12-21

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassay Systems

  2018-09-12

  BECKMAN COULTER, INC.

• Access AFP Immunoassay

  2017-10-24

  BECKMAN COULTER, INC.

• Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems

  2017-10-24

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay System

  2017-10-24

  BECKMAN COULTER, INC.

• Access Hybritech PSA Assay

  2017-10-24

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassy Systems

  2017-07-07

  BECKMAN COULTER, INC.

• Access Hybritech PSA Reagents on the Access Immunoassy Systems

  2017-07-07

  BECKMAN COULTER, INC.

• Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

  2017-07-07

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2017-07-07

  BECKMAN COULTER, INC.

• Access AFP Reagents on the Access Immunoassay Systems

  2017-06-16

  BECKMAN COULTER, INC.

• Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

  2017-06-16

  BECKMAN COULTER, INC.

171 records. Showing 1-40. Next

PMN#

• Access Toxo IgM II

  2024-10-11

  Beckman Coulter, Inc.

• Access Syphilis

  2024-09-06

  Beckman Coulter, Inc.

• Access TPO Antibody

  2024-08-09

  Beckman Coulter, Inc.

• UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

  2024-07-05

  Beckman Coulter, Inc.

• Access Thyroglobulin Antibody II

  2024-07-03

  Beckman Coulter, Inc.

• Access sTfR

  2024-07-03

  Beckman Coulter, Inc.

• Access Thyroglobulin

  2024-06-28

  Beckman Coulter, Inc.

• Access Thyroglobulin

  2024-06-07

  Beckman Coulter, Inc.

• Access OV Monitor

  2024-05-10

  Beckman Coulter, Inc.

• Access BR Monitor

  2024-05-09

  Beckman Coulter, Inc.

• Access Intrinsic Factor Ab

  2024-05-03

  Beckman Coulter, Inc.

• Access EPO

  2024-04-22

  Beckman Coulter, Inc.

• Access NT-proBNP

  2024-04-12

  Beckman Coulter, Inc.

• Access Ferritin

  2024-03-20

  Beckman Coulter, Inc.

• Access Free T4

  2024-03-06

  Beckman Coulter, Inc.

• Access Intact PTH

  2024-03-01

  Beckman Coulter, Inc.

• Access CK-MB

  2024-02-16

  Beckman Coulter, Inc.

• Access SHBG

  2024-02-08

  Beckman Coulter, Inc.

• Access hsTnI

  2023-12-18

  Beckman Coulter, Inc.

• Access hsTnI

  2023-12-04

  Beckman Coulter, Inc.

• DxFLEX Flow Cytometer; ClearLLab 10C Panels

  2023-11-22

  Beckman Coulter, Inc.

• Access Thyroglobulin Antibody II

  2023-09-26

  Beckman Coulter, Inc.

• Access CEA

  2023-09-22

  Beckman Coulter, Inc.

• Access Myoglobin

  2023-09-18

  Beckman Coulter, Inc.

• Access Thyroglobulin

  2023-09-15

  Beckman Coulter, Inc.

• Access Folate Assay

  2023-08-23

  Beckman Coulter, Inc.

• Access PCT

  2023-04-26

  Beckman Coulter, Inc.

• MicroScan Prompt Inoculation System-D

  2023-04-05

  Beckman Coulter, Inc.

• Access Cortisol

  2023-02-08

  Beckman Coulter, Inc.

• Access AMH

  2023-02-03

  Beckman Coulter, Inc.

• Access 25(OH) Vitamin D Total

  2023-01-19

  Beckman Coulter, Inc.

• Access Testosterone

  2023-01-13

  Beckman Coulter, Inc.

• Access Total ßhCG (5th IS)

  2022-12-27

  Beckman Coulter, Inc.

• Access Vitamin B12

  2022-12-23

  Beckman Coulter, Inc.

• Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

  2022-11-10

  Beckman Coulter, Inc.

• Total Immunoglobulin E (IgE)

  2022-03-23

  Beckman Coulter, Inc.

• Counter, Differential Cell

  2021-12-15

  Beckman Coulter, Inc.

• IQ200 System, IChemVELOCITY Automated Urine Chemistry System

  2021-07-02

  Beckman Coulter, Inc.

• MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)

  2021-05-18

  Beckman Coulter, Inc.

• MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )

  2020-11-16

  Beckman Coulter, Inc.

200 records. Showing 1-40. Next

GUDID#

• DxU - DxU 1800 System Bridge System bridge is an interface for the DxU 1800c fully automated urine chemistry analyzer that facilitates post-analytical processing and the transfer of patient samples within a clinical laboratory.

  Beckman Coulter, Inc.

  2026-06-24

• MicroScan - MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US)

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan LabPro V5.03 Data Delivery 07 (US), Electronic

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan LabPro V5.03 Panel Update 11 (US), Electronic

  Beckman Coulter, Inc.

  2025-12-08

• UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter) - D30863

  Beckman Coulter, Inc.

  2026-05-19

• Access anti-HBc IgM - The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitativedetection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) andadult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2)EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] usingthe DxI 9000 Access Immunoassay Analyzer.The Access anti-HBc IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis Bvirus (HBV) infection in individuals with signs and symptoms of hepatitis, when used in conjunction with other serologicaland clinical information.The Access anti-HBc IgM assay is for use on the DxI 9000 Access Immunoassay Analyzer only.This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

  Beckman Coulter, Inc.

  2026-05-04

• Access anti-HBc IgM Calibrator - The Access anti-HBc IgM Calibrator is intended to calibrate the Access anti-HBc IgM assay for the in vitro qualitativedetection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human serum and plasma using the DxI9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-05-04

• Access anti-HBc IgM QC - The Access anti-HBc IgM QC is intended for monitoring system performance of the Access anti-HBc IgM assay. TheAccess anti-HBc IgM QC is for use on the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-05-04

• Access anti-HAV IgM - The Access anti-HAV IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, and tripotassium (K3) EDTA] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HAV IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis A virus (HAV) infection in individuals with signs and symptoms of hepatitis A virus, when used in conjunction with other serological and clinical information.This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps).

  Beckman Coulter, Inc.

  2026-04-23

• Access anti-HAV IgM Calibrator - The Access anti-HAV IgM Calibrator is intended to calibrate the Access anti-HAV IgM assay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-04-23

• Access anti-HAV IgM QC - The Access anti-HAV IgM QC is intended for monitoring system performance of the Access anti-HAV IgM assay. The Access anti-HAV IgM QC is for use on the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-04-23

• Synchron - Glucose Reagent (Glucose Oxidase)

  Beckman Coulter, Inc.

  2016-08-24

• Access BNP II - The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:• as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure• for the risk stratification of patients with acute coronary syndromes• for the risk stratification of patients with heart failure

  Beckman Coulter, Inc.

  2026-03-30

• Hepatitis B Virus core Total Antibody - The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitativedetection of total antibodies to hepatitis B virus core antigen (anti-HBc) in human pediatric (2 through 21 years) and adultserum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA,tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD) and citrate phosphate dextrose (CPD)] using theDxI 9000 Access Immunoassay Analyzer.The Access anti-HBc Total assay may be used as an aid in the laboratory diagnosis of acute, chronic or resolved hepatitisB virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, includingpregnant women, when used in conjunction with other laboratory results and clinical information.The Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only.This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

  Beckman Coulter, Inc.

  2026-03-30

• ACCESS anti-HBc Total CALIBRATOR - The Access anti-HBc Total Calibrator is intended to calibrate the Access anti-HBc Total assay for the in vitroqualitative detection of hepatitis B virus core total antibodies (anti-HBc) in human serum and plasma using theDxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-03-30

• ACCESS anti-HBc Total QC - The Access anti-HBc Total QC is intended for monitoring system performance of the Access anti-HBc Total assay. TheAccess anti-HBc Total QC is for use on the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-03-30

• Cytomics FC500 - Cytomics FC 500 MPL with MXP Software

  Beckman Coulter, Inc.

  2016-09-23

• Cytomics FC500 - Cytomics FC 500 with CXP Software

  Beckman Coulter, Inc.

  2016-09-23

• Access PCT - The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.

  Beckman Coulter, Inc.

  2023-05-05

• ACCESS HBsAg - The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human pediatric (7 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA,tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer.The Access HBsAg assay is used for the laboratory diagnosis of acute or chronic hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, when used in conjunction with other serological and clinical information. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.

  Beckman Coulter, Inc.

  2026-01-16

• ACCESS HBsAg Confirmatory - The Access HBsAg Confirmatory assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human pediatric (7 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] that have been found to be repeatedly reactive in the Access HBsAg assay using the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-01-16

• Access HBsAg CALIBRATOR - The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and Access HBsAg Confirmatory assays forthe in vitro qualitative detection and confirmation of hepatitis B surface antigen (HBsAg) in human serum and plasmausing the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-01-16

• ACCESS HBsAg QC - The Access HBsAg QC is intended for monitoring system performance of the Access HBsAg and Access HBsAgConfirmatory assays. The Access HBsAg QC is for use on the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-01-16

• ACCESS anti-HAV - The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer.The Access anti-HAV assay is indicated as an aid in the diagnosis of current or past HAV infection in persons with risk factors and/or signs or symptoms of hepatitis A, when used in conjunction with other serological and clinical information. The assay may also be used in the identification of HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients.This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps).

  Beckman Coulter, Inc.

  2026-01-16

• ACCESS anti-HAV CALIBRATOR - The Access anti-HAV Calibrator is intended to calibrate the Access anti-HAV assay for the in vitro qualitative detection of antibodies to hepatitis A virus (anti-HAV IgG and IgM) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-01-16

• ACCESS anti-HAV QC - The Access anti-HAV QC is intended for monitoring system performance of the Access anti-HAV assay. The Access anti-HAV QC is for use on the DxI 9000 Access Immunoassay Analyzer.

  Beckman Coulter, Inc.

  2026-01-16

• MicroScan - MicroScan Rapid Anaerobe ID Panel

  Beckman Coulter, Inc.

  2022-12-05

• MicroScan - MicroScan Rapid Yeast ID Panel

  Beckman Coulter, Inc.

  2022-12-05

• Access BR Monitor - The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breastcancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

  Beckman Coulter, Inc.

  2016-09-09

• MicroScan - MicroScan LabPro V5.03 System (US), Electronic

  Beckman Coulter, Inc.

  2025-12-17

• MicroScan - MicroScan LabPro Connect V5.03 System (US), Electronic

  Beckman Coulter, Inc.

  2025-12-17

• MicroScan - MicroScan LabPro V5.03 System DVD Kit (US)

  Beckman Coulter, Inc.

  2025-12-17

• MicroScan - MicroScan LabPro Connect V5.03 System DVD Kit (US)

  Beckman Coulter, Inc.

  2025-12-17

• MicroScan - MicroScan Neg MIC 65

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan Neg Combo 104

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan Neg Combo 105

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan Neg Combo 106

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan Pos Combo 50

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan Pos MIC 41

  Beckman Coulter, Inc.

  2025-12-08

• MicroScan - MicroScan Neg MIC 65

  Beckman Coulter, Inc.

  2025-12-08

200 records. Showing 1-40. Next