BECKMAN COULTER, INC.

Contract manufacturer · Carlsbad, CA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

1977Product codes first listed, by year (tallest: 39)2026

FDA registration: 2050010 (openFDA record; or search FDA's registration database)
FEI number: 2050010
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: BECKMAN COULTER, INC. (FDA owner/operator no. 2050012)
Registered address: 2470 Faraday Ave, Carlsbad, CA 92010
Contract listings: 124 device listings, 120 product codes, first listed Dec 14, 1977
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Class II	Clinical chemistry	Contract manufacturing	Oct 31, 2012
CDS	Electrode, Ion Specific, Urea Nitrogen	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Class I	Clinical chemistry	Contract manufacturing	Oct 31, 2012
CEK	Biuret (Colorimetric), Total Protein	Class II	Clinical chemistry	Contract manufacturing	Jul 29, 2004
CEM	Electrode, Ion Specific, Potassium	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Class I	Clinical chemistry	Contract manufacturing	Mar 18, 2010
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Class II	Clinical chemistry	Contract manufacturing	Jul 29, 2004
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Class II	Immunology	Contract manufacturing	Aug 14, 2012
CFR	Hexokinase, Glucose	Class II	Clinical chemistry	Contract manufacturing	Dec 19, 2011
CGA	Glucose Oxidase, Glucose	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Class II	Clinical chemistry	Contract manufacturing	Mar 14, 2011
CGX	Alkaline Picrate, Colorimetry, Creatinine	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
CGZ	Electrode, Ion-Specific, Chloride	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Class I	Clinical chemistry	Contract manufacturing	Jul 29, 2004
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Class I	Clinical chemistry	Contract manufacturing	Apr 29, 1996
CHW	Titrimetric With Edta And Indicator, Calcium	Class II	Clinical chemistry	Contract manufacturing	Oct 31, 2012
CIG	Diazo Colorimetry, Bilirubin	Class II	Clinical chemistry	Contract manufacturing	Aug 1, 2011
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Class II	Clinical chemistry	Contract manufacturing	Mar 14, 2011
CIX	Bromcresol Green Dye-Binding, Albumin	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Class II	Clinical chemistry	Contract manufacturing	Aug 31, 2010
CJW	Bromcresol Purple Dye-Binding, Albumin	Class II	Clinical chemistry	Contract manufacturing	Jan 5, 2012
CJY	Azo Dye, Calcium	Class II	Clinical chemistry	Contract manufacturing	Oct 31, 2012
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Class I	Clinical chemistry	Contract manufacturing	Jul 29, 2004
CZP	Iga, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Oct 31, 2012
CZW	Complement C3, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DAD	Haptoglobin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Dec 16, 1977
DBF	Ferritin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Dec 30, 2009
DBI	Complement C4, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DCF	Albumin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	May 10, 2010
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Class II	Immunology	Contract manufacturing	Jan 5, 2012
DCN	System, Test, C-Reactive Protein	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DDG	Transferrin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Dec 30, 2011
DDQ	Antigen, Antiserum, Control, Antithrombin Iii	Class II	Hematology	Contract manufacturing	Feb 1, 2013
DDS	Prealbumin, Fitc, Antigen, Antiserum, Control	Class I	Immunology	Contract manufacturing	Feb 1, 2013
DDT	Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Oct 31, 2012
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DEH	Lambda, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Dec 18, 2012
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Aug 2, 2011
DEW	Igg, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Oct 17, 2011
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Aug 1, 2011
DFH	Kappa, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Dec 18, 2012
DFT	Igm, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Oct 31, 2012
DGC	Ige, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DHR	System, Test, Rheumatoid Factor	Class II	Immunology	Contract manufacturing	Oct 31, 2012
DIF	Drug Mixture Control Materials	Class I	Clinical toxicology	Contract manufacturing	Feb 1, 2013
DIH	Colorimetry, Cholinesterase	Class I	Clinical toxicology	Contract manufacturing	Aug 31, 2010
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
DIP	Enzyme Immunoassay, Diphenylhydantoin	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
DIS	Enzyme Immunoassay, Barbiturate	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
DJG	Enzyme Immunoassay, Opiates	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
DJR	Enzyme Immunoassay, Methadone	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
DKB	Calibrators, Drug Mixture	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
DKC	Alcohol Control Materials	Class I	Clinical toxicology	Contract manufacturing	Feb 4, 2013
DKJ	Colorimetry, Salicylate	Class II	Clinical toxicology	Contract manufacturing	Sep 6, 2012
DKZ	Enzyme Immunoassay, Amphetamine	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
DLJ	Calibrators, Drug Specific	Class II	Clinical toxicology	Contract manufacturing	Sep 1, 2010
DLZ	Enzyme Immunoassay, Phenobarbital	Class II	Clinical toxicology	Contract manufacturing	Jan 5, 2012
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
DNN	Calibrators, Ethyl Alcohol	Class II	Clinical toxicology	Contract manufacturing	Feb 1, 2013
GGK	Products, Red-Cell Lysing Products	Class I	Hematology	Contract manufacturing	Dec 14, 1977
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Class I	Microbiology	Contract manufacturing	Jul 29, 2004
GTR	Antideoxyribonuclease, Streptococcus Spp.	Class I	Microbiology	Contract manufacturing	Sep 27, 1983
JBQ	Antithrombin Iii Quantitation	Class II	Hematology	Contract manufacturing	Feb 1, 2013
JCB	Detergent	Class I	Pathology	Contract manufacturing	Dec 14, 1977
JFJ	Catalytic Methods, Amylase	Class II	Clinical chemistry	Contract manufacturing	May 10, 2010
JFL	Ph Rate Measurement, Carbon-Dioxide	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
JFM	Enzymatic Method, Bilirubin	Class II	Clinical chemistry	Contract manufacturing	Aug 29, 2012
JFP	Electrode, Ion Specific, Calcium	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
JFY	Enzymatic Method, Creatinine	Class II	Clinical chemistry	Contract manufacturing	Sep 16, 2009
JGG	L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase	Class I	Clinical chemistry	Contract manufacturing	Oct 31, 2012
JGJ	Photometric Method, Magnesium	Class I	Clinical chemistry	Contract manufacturing	Dec 30, 2011
JGS	Electrode, Ion Specific, Sodium	Class II	Clinical chemistry	Contract manufacturing	Aug 13, 2009
JHW	U.V. Method, Cpk Isoenzymes	Class II	Clinical chemistry	Contract manufacturing	Oct 31, 2012
JIF	Enzymatic Method, Ammonia	Class I	Clinical chemistry	Contract manufacturing	Sep 12, 2012
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Class I	Clinical chemistry	Contract manufacturing	Feb 1, 2013
JIS	Calibrator, Primary	Class II	Clinical chemistry	Contract manufacturing	Aug 1, 2011
JIT	Calibrator, Secondary	Class II	Clinical chemistry	Contract manufacturing	Dec 30, 2009
JIX	Calibrator, Multi-Analyte Mixture	Class II	Clinical chemistry	Contract manufacturing	Mar 18, 2010
JIY	Photometric Method, Iron (Non-Heme)	Class I	Clinical chemistry	Contract manufacturing	Jan 5, 2012
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	Mar 18, 2010
JJW	Urinalysis Controls (Assayed And Unassayed)	Class I	Clinical chemistry	Contract manufacturing	Sep 24, 2014
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Class I	Clinical chemistry	Contract manufacturing	Feb 1, 2013
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Class I	Clinical chemistry	Contract manufacturing	Feb 1, 2013
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Class I	Clinical chemistry	Contract manufacturing	Dec 30, 2011
JOB	Hexane Extraction, Fluorescence, Vitamin E	Class I	Clinical chemistry	Contract manufacturing	Oct 31, 2012
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Class I	Clinical chemistry	Contract manufacturing	Aug 31, 2010
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Class I	Clinical chemistry	Contract manufacturing	Jul 29, 2004
JXM	Enzyme Immunoassay, Benzodiazepine	Class II	Clinical toxicology	Contract manufacturing	Jan 5, 2012
JXN	Enzyme Immunoassay, Propoxyphene	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
JZG	System, Test, Beta-2-Microglobulin Immunological	Class II	Immunology	Contract manufacturing	Feb 6, 2013
JZH	Factor B, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Feb 1, 2013
JZJ	Prealbumin, Antigen, Antiserum, Control	Class I	Immunology	Contract manufacturing	Oct 31, 2012
KHE	Reagent, Occult Blood	Class II	Hematology	Contract manufacturing	Apr 29, 2010
KHQ	Radioassay, Triiodothyronine Uptake	Class II	Clinical chemistry	Contract manufacturing	Oct 31, 2012
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Class II	Clinical chemistry	Contract manufacturing	Oct 31, 2012
KLS	Enzyme Immunoassay, Theophylline	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
KLT	Enzyme Immunoassay, Carbamazepine	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
KNK	Acid, Uric, Uricase (Colorimetric)	Class I	Clinical chemistry	Contract manufacturing	Dec 30, 2011
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Class II	Hematology	Contract manufacturing	Feb 1, 2013
KXS	Radioimmunoassay, Methaqualone	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
KXT	Enzyme Immunoassay, Digoxin	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Class I	Clinical chemistry	Contract manufacturing	Mar 29, 2004
LCD	Enzyme Immunoassay, Gentamicin	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
LCM	Enzyme Immunoassay, Phencyclidine	Unclassified	Clinical toxicology	Contract manufacturing	Oct 31, 2012
LCP	Assay, Glycosylated Hemoglobin	Class II	Hematology	Contract manufacturing	Oct 31, 2012
LCQ	Fluorescent Immunoassay Gentamicin	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
LCR	Fluorescent Immunoassay, Tobramycin	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
LDJ	Enzyme Immunoassay, Cannabinoids	Class II	Clinical toxicology	Contract manufacturing	Dec 31, 2009
LDP	Colorimetry, Acetaminophen	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
LEG	Enzyme Immunoassay, Valproic Acid	Class II	Clinical toxicology	Contract manufacturing	Oct 31, 2012
LEH	Radioimmunoassay, Vancomycin	Class II	Clinical toxicology	Contract manufacturing	Sep 1, 2010
LFN	Nephelometric Inhibition Immunoassay, Phenobarbital	Class II	Clinical toxicology	Contract manufacturing	Dec 22, 2009
LFP	Conductivity Rate, Urea Nitrogen	Class II	Clinical chemistry	Contract manufacturing	Jan 5, 2012
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Class I	Immunology	Contract manufacturing	Dec 18, 2023
MGA	Alpha-1 Microglobulin, Antigen, Antiserum, Control	Class I	Immunology	Contract manufacturing	Aug 2, 2011
MRR	System, Test, Low Density, Lipoprotein	Class I	Clinical chemistry	Contract manufacturing	Sep 27, 2001
MSJ	Apolipoproteins	Class I	Clinical chemistry	Contract manufacturing	Feb 1, 2013
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Class II	Immunology	Contract manufacturing	May 29, 2008
PPM	General Purpose Reagent	Class I	Pathology	Contract manufacturing	Jul 24, 2006

BECKMAN COULTER, INC.

Devices listed as contract work

Other contract facilities of BECKMAN COULTER, INC.