FDA.reportPublic FDA data

BECKMAN COULTER, INC.

Matched from indexed company URL: Beckman Coulter

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10178351017835BECKMAN COULTER, INC.1N2026-01-01740 WEST 83RD ST. HIALEAH FL US 33014
10619323000203293BECKMAN COULTER, INC.1N2026-01-0111800 SW 147TH AVE. Miami FL US 33196
20500102050010BECKMAN COULTER, INC.1N2026-01-012470 Faraday Ave CARLSBAD CA US 92010
20500122050012BECKMAN COULTER, INC.1Y2026-01-01250 S Kraemer Blvd BREA CA US 92821
21228702122870BECKMAN COULTER, INC.1Y2026-01-011000 LAKE HAZELTINE DR. CHASKA MN US 55318
29190162919016Beckman Coulter, Inc.1N2026-01-011584 Enterprise Blvd West Sacramento CA US 95691
30041983943004198394BECKMAN COULTER, INC.1N2026-01-015350 Lakeview Parkway South Dr INDIANAPOLIS IN US 46268
30074481243007448124Beckman Coulter, Inc1N2026-01-015355 W. 76th Street Indianapolis IN US 46268
30086297853008629785Beckman Coulter, Inc.1N2026-01-012295 Progress Dr. Suite C Hebron KY US 41048
30213948623021394862Beckman Coulter Biomedical GmbH1N2026-01-01Kuehler Weg 1 Baierbrunn Bavaria DE 82065
10348861034886BECKMAN COULTER, INC.1N2020-04-257381 EMPIRE DR. FLORENCE KY US 41042
30032447103003244710Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.1N2020-04-25No. 181 West Su Hong Road Suzhou Industrial Park Suzhou Jiangsu CN 215021
30106868563010686856Beckman Coulter India Private Limited1N2020-04-25Bangalore Development Center #50-B 2nd Phase, Near TVS Cross Peenya Industrial Area Bengaluru Karnataka IN 560058
30135136073013513607Beckman Coulter GmbH1N2020-04-25Frauenberg Str. 31 Marburg Hessen DE D-35041

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
52651916923527P980041ACCESS AFP IMMUNOASSAY SYSTEMLOK1999-02-08
52651983974987P970038TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAYMTG1998-03-10
1805691390672708P870049MICROSCAN RAPID PANELSLON1988-02-24
52651392937718P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAYMTF1986-02-25
52651720188432P090026ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMSOYA2012-06-14
52651259848934K994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYCIN2000-03-28
52651776628652K994277ACCESS OSTASE QCJJX2000-01-14
52651423505104K994200ACCESS HYBRITECH PSA QC, MODEL 37209JJX2000-01-18
52591671570126K994168SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATORJIS2000-02-03
52591225792899K993954SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORSDKB2000-01-11
52591311222435K993547BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREBCFN2000-02-01
52591605584423K993473SYNCHRON SYSTEMS DRUG CALIBRATOR 2DLJ1999-11-26
52651691020928K993210ACCESS HYBRITECH FREE PSA QC, MODEL 37219JJX2000-01-05
1805691991932618K993102DRIED GRAM-POSITIVE MIC/COMBO PANELSLTT1999-12-02
52591981979228K993065ACON COMBO PREGNANCYJHI1999-10-08
52701981979228K993065ACON COMBO PREGNANCYJHI1999-10-08
52591086352708K993023SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLSJJY1999-11-26
52591503746692K993022SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORSDLJ1999-11-09
52591979860894K992511ABX PENTRA 60 HEMATOLOGY ANALYZERGKZ1999-10-15
52701979860894K992511ABX PENTRA 60 HEMATOLOGY ANALYZERGKZ1999-10-15
52591490859743K990352COULTER AC T DIFF 2 ANALYZERGKZ1999-04-01
52701490859743K990352COULTER AC T DIFF 2 ANALYZERGKZ1999-04-01
52591682024224K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSGKZ1999-04-26
52671682024224K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSGKZ1999-04-26
52701682024224K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSGKZ1999-04-26
52591530491837K990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAGKZ1999-04-13
52701530491837K990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAGKZ1999-04-13
52591495836614K984402SYNCHRON SYSTEMS AMMONIA (AMM) REAGENTJIF1999-01-29
52591466482381K984216IMMUNO-TROL CONTROL CELLSJPK1999-03-16
52701466482381K984216IMMUNO-TROL CONTROL CELLSJPK1999-03-16
52591522269577K984152SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENTDJG1999-01-29
52591484478185K983709SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1DIF1998-10-28
52591808135442K983640SYNCHRON SYSTEMS LIPID CALIBRATORJIS1998-12-21
52591858341396K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
52701858341396K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
52591433817203K983340IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATORDBF1998-12-14
52591495720686K982935SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATORKXT1998-10-14
52651075537151K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCEC1998-07-14
52591814612626K982224VIGIL PROTEIN CONTROLJJY1998-07-09
52591836513090K982172CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COLGKZ1998-09-24
52701836513090K982172CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COLGKZ1998-09-24
52591888366708K982167CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-09
52701888366708K982167CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-09
52591145376821K982166CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-05
52701145376821K982166CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-05
52591265287796K982022VIGIL HEMOGLOBIN (HBALC) CONTROLSJJX1998-07-06
52651417711427K981985ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209DHX1998-09-24
52651979000901K981864ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219JJX1998-06-12
52591781940815K981638IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENTDCK1998-06-12
1805691433276525K981199MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREENLRG1998-11-18
52591619463249K974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)JIF1998-01-02
52592066571597K974564IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENTDEB1998-02-17
52591822271747K974452VIGIL LIPID CONTROLJJY1997-12-17
52591819319978K974110IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENTJBQ1997-12-24
52591439956095K974050SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENTDCK1997-11-24
52651131175901K973966ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCDP1997-10-31
52591839400454K973932BECKMAN CALIBRATOR 2 (CAL2)JIX1997-12-15
52591754844327K973928BECKMAN URINE PROTEIN CALIBRATOR (UCAL)JIX1997-12-01
52591386377706K973634COULTER AC.T DIFF ANALYZERGKZ1997-10-29
52701386377706K973634COULTER AC.T DIFF ANALYZERGKZ1997-10-29
52591194207491K973069SYNCHRON SYSTEMS METHADONE REAGENTDJR1997-09-22
52591808719908K972819VIGIL TDM CONTROLSDIF1997-08-13
1805691674821166K972799DRIED GRAM-POSITIVE MIC/COMBO PANELSLTT1997-10-10
1805691426863075K972688MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACINJWY1997-09-08
52591494398348K971958SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENTDDG1997-08-20
52591902027938K971534SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROLDIF1997-05-21
1805691608079266K971376DRIED GRAM-NEGATIVE MIC/COMBO PANELSJWY1997-05-30
52592057142392K971333SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYDJIX1997-05-23
52591227027092K971287SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUSDKB1997-05-08
52591055119303K971283SYNCHRON SYSTEMS CAL 5 PLUSJIX1997-06-03
52591350660173K971210SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLSLAS1997-04-17
52591092506688K970919SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENTKNK1997-05-21
1805691309237940K970676DRIED GRAM-NEGATIVE MIC/COMBO PANELSJWY1997-05-02
52591604711202K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSMSJ1997-04-21
52591521976446K965240SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON LJJE1997-03-10
52592059504877K965108SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENTDEW1997-03-06
52591029261031K965035IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTJIQ1997-04-17
52591155191421K965033IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENTMGA1997-04-21
52591918115472K964988COULTER AC.T SERIES ANALYZERGKZ1997-03-06
52701918115472K964988COULTER AC.T SERIES ANALYZERGKZ1997-03-06
52591363872757K964843IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENTJZH1997-03-06
52591799020823K964842IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENTCZW1997-06-11
52592005694565K964781IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENTDDS1997-05-09
52591089204213K964766IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)DEM1997-04-25
52591477197445K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTDDB1997-04-25
52591063501015K964695IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENTDCF1997-04-29
52591958693108K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1GKZ1996-12-23
52701958693108K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1GKZ1996-12-23
52591038592174K964260IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAGDFH1997-02-10
52591022587960K964257IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENTLKL1997-03-24
52591035474500K964010IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENTMSJ1997-02-10
52591714818281K963976IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENTDDG1997-03-19
52591052501038K963974IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULINDEW1997-03-06
52591004116326K963868IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)DEW1997-02-10
52591559883437K963427IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENTDDG1996-10-07
52591161876604K963286IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENTDAD1996-10-07
52591289125070K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5GKZ1997-01-22
52671289125070K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5GKZ1997-01-22
52701289125070K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5GKZ1997-01-22
52591096102389K963048IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENTDHR1996-11-04
52671482109484K962988COULTER GEN-S SYSTEMGKL1996-10-30
52591946880680K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROLGKZ1997-01-06
52701946880680K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROLGKZ1997-01-06
52591093572004K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROLGKZ1997-01-06
52701093572004K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROLGKZ1997-01-06
52591082688856K962294IMMAGE IMMUNOCHEMISTRY SYSTEMJQX1996-08-21
2290001082688856K962294IMMAGE IMMUNOCHEMISTRY SYSTEMJQX1996-08-21
1805691003229200K962150DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELSLTT1996-08-16
52701430315781K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
52592072597944K960485SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTSJMO1996-05-10
1805691190187767K955910DRIED GRAM-NEGATIVE MIC/COMBO PANELSJWY1996-02-23
52651469047404K955769ACCESS PROGESTERONE ASSAYJLS1996-02-05
52591260774089K955677SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENTLDJ1996-04-03
52571803059983K955676SYNCHRON SYSTEMS METHAQUALONE REAGENTKXS1996-03-04
52591803059983K955676SYNCHRON SYSTEMS METHAQUALONE REAGENTKXS1996-03-04
52591949411972K955675SYNCHRON SYSTEMS PROPOXYPHENE REAGENTJXN1996-02-09
52591475017749K955644SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEMKLT1996-02-16
52651054552816K955436ACCESS VITAMIN B12 ASSAY (MODIFICATION)CDD1996-01-24
52651945104144K955434ACCESS FOLATE ASSAY (MODIFICATION)CGN1996-01-29
52591432696901K9550164C PLUS COULTER CELL CONTROLJPK1996-01-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ942024-07-05
JWY412021-05-18
LTT372025-08-20
LRG272011-08-04
JPK252009-02-03
JIX92011-05-25
MMI82023-12-18
JIT82015-02-26
JJX72011-11-04
JJY72001-03-05
DDG52024-07-03
JHI52002-12-20
NBC42026-03-24
LGD42025-03-28
CDZ42024-02-08
CDD42022-12-23
JLW42022-11-10
OYE42017-06-23
LCP42014-07-14
KQO42011-03-23
JIS42001-05-10
DEW41997-03-06
CGR32025-03-05
JNL32024-07-03
MSW32024-06-28
DHX32023-09-22
CGN32023-08-23
LON32020-08-30
PWD32019-03-21
CFR32014-04-17
LKM32010-02-05
KHE32008-06-25
JJW32007-12-21
NQD32007-06-21
CGX32007-06-01
CDT32007-03-23
DCK32001-04-05
DIF31998-10-28
LDJ31996-04-03
LFX22025-11-17

PMA#

Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

2022-12-16

BECKMAN COULTER, INC.1000 Lake Hazeltine Dr.chaska, MN 55318 PMA NumberP090026 Supplement NumberS031 Date Received04/19/2021 Decision Date12/16/2022 Product Code OYA  Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change De...

Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

2022-12-16

BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP970038 Supplement NumberS045 Date Received04/19/2021 Decision Date12/16/2022 Product Code MTG  Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Cha...

Access Hybritech PSA Reagents on the Access Immunoassay Systems

2022-03-03

BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP850048 Supplement NumberS058 Date Received02/04/2022 Decision Date03/03/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process...

174 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

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-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 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 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 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 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

80 records. Showing 1-40. Next