Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2050012

FEI Number

2050012

Entity Name

BECKMAN COULTER, INC.

City/State/Country

BREA, CA, US

Establishment Address

250 S Kraemer Blvd, BREA, CA 92821, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BECKMAN COULTER, INC. (Owner Number: 2050012)

Owner / Operator Contact Address

250 S. Kraemer Blvd, --, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120199

PMA Number

N/A

All Registered Proprietary Names

475100 Microalbumin Reagent (MA 2 x 100) 474620 IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent 441470 Immunochemistry Systems UCAL Urine Protein Calibrator A38656 IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent 469975 CAL 5 PLUS Calibrator 5 Plus Immage CAL 5 Plus Part numbers include, but are not limited to Immage CCRP reagent 445930 SYNCHRON Systems Microprotein Calibrator 446410 IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent 447730 IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent StatSpin Cytofuge 2 (P/N X00-003066-001) SatSpin CritSpin Digital Reader (P/N X00-003808-001) SatSpin MP (P/N X00-004998-001) StatSpin Express 3 (P/N X00-005222-001) StatSpin Express 4 (P/N X00-005531-001) StatSpin Express 2 (P/N X00-003856-002) 474982 SYNCHRON Systems OP 300 Low Urine Calibrator 474985 SYNCHRON Systems OP 300 High Urine Calibrator 442640 Synchron Glucose 2 x 300 GLU Reagent 441350 SYNCHRON Systems Enzyme Validator Set Levels 1 & 2 650218 SYNCHRON Systems Lipid Calibrator Levels 1 & 2 Enzymatic Creatinine Reagent (CR-E 2 x 200) 468429 IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator 447160 IMMAGE Immunochemistry Systems FER Ferritin Reagent 447740 IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent 469283 APO CAL Apolipoprotein Calibrator 378194 Salicylate Reagent (SALY 2 x 45) Synchron Salicylate test system 445850 Triglycerides Reagent (TG 2 x 300) 475024 Opiate 300 ng Reagent (OP 1 x 250) 447750 IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent 447720 IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent A53722 Synchron Cholinesterase (CHEX) Reagent 445360 Magnesium Reagent (MG 2 x 100) SYNCHRON Magnesium A09426 Phosphorus Reagent (PHS 2 x300) 475003 Cocaine Metabolite Reagent (COCM 1 x 250) 465300 Immunochemistry Systems Level 2 Urine Protein Control 465290 Immunochemistry Systems Level 1 Urine Protein Control B24985 Glucose Reagent GLUH 2 x 300 442785 Uric Acid Reagent (URIC 2 x 300) SYNCHRON Uric acid 472169 Acetaminophen Reagent (ACTM 100) 449560 Immunochemistry Systems CAL 1 Calibrator 1 446480 IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent 474973 SYNCHRON System DAT Multi-Drug High Urine Calibrator 474970 SYNCHRON Systems DAT Multi-Drug Low Urine Calibrator 469112 Carbamazepine Reagent (CAR 2 x 100) 469785 Phenobarbital Reagent (PHE 2 x 100) 469188 Phenytoin Reagent (PHY 2 x 100) 467983 Tobramycin Reagent (TOB 2 x 100) 469600 SYNCHRON Systems Drug Calibrator 1 469137 Gentamicin Reagent (GEN 2 x 100) 469126 Theophylline Reagent (THE 2 x 100) 447760 IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent 449730 Immunochemistry Systems CAL 3 Calibrator 3 447600 IMMAGE Immunochemistry Systems ALB Albumin Reagent 467995 Valproic Acid Reagent (VPA 2 x 100) 447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent 447620 IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent 469165 Antistreptolysin-O Reagent (ASO- 2 x 100) OSR6194 ASO 472110 SYNCHRON Systems 40 ng/mL THC Urine Control 472107 SYNCHRON Systems 10 ng/mL THC Urine Control 439770 Ammonia Reagent (AMM 2 x 25) Synchron AMM reagent and calibrators Part numbers include, but are not limited to 969650 Pancreatic Amylase Reagent (PAM 2 x 60) 450162 Vigil Serology Control Level 1 450163 Vigil Serology Control Level 2 450164 Vigil Serology Control Level 3 446440 IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent 446470 IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent 445824 Cannabinoid 20 ng Reagent (THC2 1 x 150) 464390 SYNCHRON Systems 20 ng/mL THC Urine Calibrator 465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 447450 IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent 447780 IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent 475081 SYNCHRON Systems PAB Calibrator 447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent StatSpin MP Centrifuge A87905 Hemoglobin A1c Reagent (HbA1c- 400) 447700 IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent 447070 IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent ENZYMATIC BILIRUBIN REAGENT 683802 Enzymatic Bilirubin Reagent 450125 Vigil Protein Control Level 2 450130 Vigil Protein Control Level 3 450120 Vigil Protein Control Level 1 447630 IMMAGE Immunochemistry Systems TRF Transferrin Reagent 442600 SYNCHRON Systems SYNCHRON Multi Calibrator SYNCHRON Systems AQUA CAL 1, 2, 3 SYNCHRON Systems Creatinine Reagent SYNCHRON UniCel DxC 600i, 800i, 660i, 860i A64868 Unicel DxC 660i Synchron Access Clinical System A59102 Unicel DxC 880i Synchron Access Clinical System A64872 UniCel DxC 660i - Full System A64936 UniCel DxC 860i - Full System A27318 Unicel DxC 600i Synchron Access Clinical System A64869 Unicel DxC 680i Synchron Access Clinical System A64935 UniCel DxC 860i - Full System Domestic A64903 UniCel DxC 680i - Full System Domestic A64871 UniCel DxC 660i - Full System Domestic A64870 Unicel DxC 860i Synchron Access Clinical System A64904 UniCel DxC 680i - Full System 465970 Total Iron Binding Capacity Reagent (IBCT 2 x 100) 465971 Total Iron Binding Capacity Reagent (IBCT 2 x 100) 442772 SYNCHRON Systems FE/IBCT Calibrator Kit 467910 Iron Reagent (FE 2 x 200) 465976 SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit 445860 Microprotein Reagent (M-TP 2 x 50) SYNCHRON Micro Total Protein 969620 C-Reactive Protein Reagent (C-RP 2 x 200) 378020 High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200) Part numbers include, but are not limited to Synchron CRPH reagent 465980 Vigil Lipid Control Level 2 469905 Vigil Lipid Control Level 1 465981 Vigil Lipid Control Level 3 465982 Vigil Lipid Control Level 4 447460 IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A A18298 Benzodiazepine Reagent (BNZG 1 x 250) 476821 Alkaline Phosphatase Reagent (ALP 2 x 400) 442650 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 200) 442670 Alkaline Phosphatase Reagent (ALP 2 x 200) 476846 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 400) 447610 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent 446460 IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent 446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent 467905 Apolipoprotein B Reagent (ApoB 2 x 100) 467900 Apolipoprotein A Reagent (ApoA 2 x 100) 469170 SYNCHRON Systems APO Calibrator A40920 Creatinine Reagent (CR-S 2 x 300) SYNCHRON Creatinine 442745 Total Bilirubin Reagent (TBIL 2 x 300) 476861 Total Bilirubin Reagent (TBIL 2 x 400) SYNCHRON Total Bilirubin 988462 C3 Reagent (C3 2 x 100) 988471 C4 Reagent (C4 2 x 100) 468405 SYNCHRON Systems CAL 1 Calibrator 1 467858 SYNCHRON Systems Albumin Reagent SYNCHRON Systems Glucose Reagent (Glucose Oxidase) SYNCHRON Systems CO2 Alkaline Buffer Synchron Systems Total Protein Reagent SYNCHRON Systems Phosphorus Reagent SYNCHRON Systems CO2 Acid Reagent SYNCHRON Systems Urea Nitrogen (BUN) Reagent NA+ Electrode UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon Calcium Electrode CO2 Electrode Chloride Electrode Potassium Electrode 447440 IMMAGE Immunochemistry Systems PAB Prealbumin Reagent 476851 Lipase Reagent (LIP 2 x60) 475106 Prealbumin Reagent (PAB 2 x 100) 442765 Albumin Reagent (ALB 2 x 300) 442820 Urea Reagent (UREA 2 x 300) 475089 SYNCHRON Systems MA Calibrator StatSpin Express 4 StatSpin Express 3 StatSpin Express 2 J6 Allegra, Optima, Avanti, Microfuge 443360 Synchron CX Calibration Standard 1 443365 Synchron CX Calibration Standard 2 378045 SYNCHRON Systems Vancomycin Calibrator 474824 Vancomycin Reagent (VANC 2 x 100) 469630 SYNCHRON Systems Drug Calibrator 2 OSR6165 HAPTOGLOBIN 988413 Haptoglobin Reagent (HPT 2 x 100) QUANTIPLATE OR ENDOPLATE TM HA A15445 IMMAGE 800 472472 Vigil TDM Control level 3 472467 Vigil TDM Control level 2 472461 Vigil TDM Control level 1 A15625 HDL Cholesterol Reagent HDL 2 x 200 B23634 UniCel DxC SYNCHRON Systems HDL Calibrator 475000 Amphetamines Reagent (AMPH 1 x 250) Synchron Glucose 445803 SYNCHRON Systems DAT Negative Urine Calibrator 475012 Barbiturates Reagent (BARB 1 x 250) 474979 SYNCHRON Systems DAT Multi-Drug High Urine Control 474976 SYNCHRON Systems DAT Multi-Drug Low Urine Control 475009 Phencyclidine Reagent (PCP 1 x 250) BECKMAN ENZYMATIC ALT REAGENT KIT COULTER U-V ZYME SGPT REAGENT 442620 Alanine Aminotransferase Reagent (ALT 2 x 200) 476826 Alanine Aminotransferase Reagent (ALT 2 x 400) 467848 Alanine Aminotransferase Reagent (ALT- 2 x 100) 467840 Alanine Aminotransferase Reagent (ALT- 2 x 300) 465990 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 1 465996 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 3 465993 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 2 469965 SYNCHRON Systems CAL 5 Plus SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2 Calcium Electrode Glucose Oxygen Sensor NA+ Electrode BUN Electrode Chloride Electrode Potassium Electrode CO2 Electrode 474988 SYNCHRON Systems OP 300 Low Urine Control 474991 SYNCHRON Systems OP 300 High Urine Control 471080 SYNCHRON Systems Drug Calibrator 3 Plus 467845 Aspartate Aminotransferase Reagent (AST- 2 x 300) 467849 Aspartate Aminotransferase Reagent (AST- 2 x 100) 442635 Creatine Kinase Reagent (CK 2 x 200) 442665 Aspartate Aminotransferase Reagent (AST 2 x 200) 467830 Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200) 476836 Creatine Kinase Reagent (CK 2 x 400) 476831 Aspartate Aminotransferase Reagent (AST 2 x 400) 476856 Direct Bilirubin Reagent (DBIL 2 x 300) 465915 SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR 439715 Direct Bilirubin Reagent (DBIL 2 x 200) B00389 HbA1c

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2010-05-10
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-09-12
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2012-09-12
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-15
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2013-02-15
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2013-02-01
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2014-11-17
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-12-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-04
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-04
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-02-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-12-30
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2009-12-30
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2011-08-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-04
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2012-09-06
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2013-02-01
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-02-01
DDQ	Antigen, Antiserum, Control, Antithrombin Iii	Hematology	Class 2	864.7060	2013-02-01
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2013-02-01
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Immunology	Class 2	866.5210	2013-02-01
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2012-01-05
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2011-12-30
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2013-02-01
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2013-02-01
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-18
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2013-02-18
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-18
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-09
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-12-30
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2013-02-01
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2013-02-01
LFN	Nephelometric Inhibition Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2009-12-22
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2009-12-22
LCQ	Fluorescent Immunoassay Gentamicin	Clinical Toxicology	Class 2	862.3450	2009-12-22
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2009-12-22
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2009-12-22
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2009-12-22
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2009-12-22
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2009-12-22
JZH	Factor B, Antigen, Antiserum, Control	Immunology	Class 2	866.5320	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2013-02-01
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2013-02-01
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2004-07-29
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2013-02-04
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2012-09-12
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2013-02-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-12-18
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-12-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-12-18
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2009-12-31
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2009-12-31
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2011-08-01
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-08-01
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2023-12-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2023-12-18
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-04
GTR	Antideoxyribonuclease, Streptococcus Spp.	Microbiology	Class 1	866.3720	1983-09-27
GKG	Centrifuge, Hematocrit	Hematology	Class 2	864.6400	2015-06-01
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-02-01
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2013-02-01
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2013-02-01
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2013-01-31
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2016-02-17
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-08-29
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2015-08-12
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2015-08-12
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2013-02-08
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2013-02-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-02-08
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2013-02-08
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2013-02-08
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2013-02-08
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-02-08
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2013-02-08
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-02-08
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2013-02-08
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2013-02-08
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-02-08
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2013-02-08
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-02-08
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2013-02-08
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-02-08
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2013-02-08
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-02-08
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-12-30
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2011-12-30
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2011-10-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-01
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2013-02-01
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2008-05-29
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2013-02-01
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2010-08-31
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2010-08-31
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2010-08-31
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2010-08-31
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-08-31
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2013-02-01
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-01
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2013-02-01
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-12-30
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-08-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-01
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2013-02-01
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2013-02-01
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-01-05
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2012-01-05
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-01-05
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2012-01-05
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2012-01-05
LFP	Conductivity Rate, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2012-01-05
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-01-05
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-01-05
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2012-01-05
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-01-05
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2012-01-05
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2012-01-05
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2012-01-05
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-01-05
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2012-01-05
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-01-05
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-01-05
DDS	Prealbumin, Fitc, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	1996-04-29
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2012-10-31
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2012-10-31
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-10-31
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2012-10-31
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2012-10-31
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2012-10-31
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2012-10-31
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2012-10-31
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2012-10-31
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2012-10-31
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2012-10-31
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2012-10-31
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2012-10-31
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2012-10-31
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2012-10-31
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2012-10-31
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-10-31
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-10-31
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-10-31
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2012-10-31
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2012-10-31
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-10-31
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-10-31
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2012-10-31
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2012-10-31
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-10-31
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2012-10-31
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-10-31
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2012-10-31
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2012-10-31
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-10-31
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2012-10-31
CHW	Titrimetric With Edta And Indicator, Calcium	Clinical Chemistry	Class 2	862.1145	2012-10-31
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2012-10-31
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2012-10-31
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2012-10-31
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-10-31
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2012-10-31
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2012-10-31
KXS	Radioimmunoassay, Methaqualone	Clinical Toxicology	Class 2	862.3630	2012-10-31
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-10-31
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2012-10-31
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-10-31
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2012-10-31
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2012-10-31
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2012-10-31
JOB	Hexane Extraction, Fluorescence, Vitamin E	Clinical Chemistry	Class 1	862.1815	2012-10-31
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-10-31
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2012-10-31
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2012-10-31
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2012-10-31
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-10-31
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-10-31
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-10-31
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-10-31
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2012-10-31
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2012-10-31
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2012-10-31
DDT	Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2012-10-31
JHW	U.V. Method, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2012-10-31
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2012-10-31
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2012-10-31
JGG	L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase	Clinical Chemistry	Class 1	862.1460	2012-10-31
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-04
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2004-07-29
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-15
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2013-02-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2010-09-01
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2010-09-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	1977-12-16
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-02-08
JQX	Nephelometer, For Clinical Use	Clinical Chemistry	Class 1	862.2700	2013-02-08
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-02-01
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2015-02-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-02-27
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2013-02-01
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-05
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2013-02-01
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2013-02-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-02-01
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2013-02-01
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2004-07-29
DKC	Alcohol Control Materials	Clinical Toxicology	Class 1	862.3280	2013-02-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-04
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2010-03-18
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2010-03-18
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2010-03-18
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2010-03-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-03-18
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2010-03-18
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2010-03-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2010-03-18
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2010-03-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2010-03-18
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2010-03-18
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2010-03-18
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2010-03-18
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-04
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2013-02-06
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2011-03-14
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2011-03-14
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2011-03-14
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-12-30
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-12-30
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-12-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BECKMAN COULTER, INC.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3021394862	Beckman Coulter Biomedical GmbH	Baierbrunn Bavaria, DE
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3006677029	Beckman Coulter Biomedical GmbH	Munchen Bavaria, DE
3003244710	Beckman Coulter Biotechnology (Suzhou) Co., Ltd	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905612	Ventrex Laboratories, Inc.	VENTREX COATED TUBE IGE RADIOIMMUNOASSAY	1991-02-21
K842125	Kallestad Laboratories, Inc.	ALLERCOAT ALLERGEN DISCS	1984-06-07
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0016-2013	Beckman Coulter Inc.	2	Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0032-2026	Beckman Coulter Inc.	2	DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Z-0034-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Z-0035-2013	Beckman Coulter Inc.	2	TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Z-0039-04	Beckman Coulter Inc	2	Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
Z-0040-04	Beckman Coulter Inc	2	Coulter AcT 5diff Cap Pierce Hematology Analyzers Part Numbers: 6605641, 6605705

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2050012. Last updated year: 2026. Please use registration number 2050012 when referencing this establishment in official correspondence.