FDA Registration
Active
🇺🇸 United States
BECKMAN COULTER, INC.
Reg #: 2050012
·
FEI: 2050012
·
Expires 2026
Products
128
Proprietary Names
318
Establishment Types
2
Classifications
128
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2050012
- FEI Number
- 2050012
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 250 S Kraemer Blvd
- City
- BREA
- State
- CA
- ZIP
- 92821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082251
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2010-05-10 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2013-02-01 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2013-02-04 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2012-09-12 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2013-02-15 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2013-02-15 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Cytocentrifuge | IFB | Class 1 | Pathology | No | 2014-11-17 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2011-12-19 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2013-02-04 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2016-02-17 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2009-12-30 |
| Alpha-1-Antitrypsin, Antigen, Antiserum, Control | DEM | Class 2 | Immunology | No | 2011-08-02 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2012-09-06 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Antigen, Antiserum, Control, Antithrombin Iii | DDQ | Class 2 | Hematology | No | 2013-02-01 |
| Antithrombin Iii Quantitation | JBQ | Class 2 | Hematology | No | 2013-02-01 |
| Ceruloplasmin, Antigen, Antiserum, Control | DDB | Class 2 | Immunology | No | 2013-02-01 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2012-01-05 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2011-12-30 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2013-02-18 |
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2013-02-18 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-02-18 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2011-12-30 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2013-02-01 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Nephelometric Inhibition Immunoassay, Phenobarbital | LFN | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Fluorescent Immunoassay Gentamicin | LCQ | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Fluorescent Immunoassay, Tobramycin | LCR | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Factor B, Antigen, Antiserum, Control | JZH | Class 2 | Immunology | No | 2013-02-01 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2004-07-29 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2013-02-04 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2012-09-12 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2013-02-01 |
| Kappa, Antigen, Antiserum, Control | DFH | Class 2 | Immunology | No | 2012-12-18 |
| Lambda, Antigen, Antiserum, Control | DEH | Class 2 | Immunology | No | 2012-12-18 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2009-12-31 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2011-08-01 |
| Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | LKL | Class 1 | Immunology | No | 2023-12-18 |
| Antideoxyribonuclease, Streptococcus Spp. | GTR | Class 1 | Microbiology | No | 1983-09-27 |
| Centrifuge, Hematocrit | GKG | Class 2 | Hematology | No | 2015-06-01 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2013-02-01 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2013-02-01 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2013-02-01 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2013-01-31 |
| Enzymatic Method, Bilirubin | JFM | Class 2 | Clinical Chemistry | No | 2016-02-17 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2015-08-12 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | No | 2013-02-08 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2013-02-08 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2013-02-08 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2013-02-08 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2013-02-08 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2013-02-08 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2013-02-08 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2011-12-30 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2013-02-01 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2013-02-01 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2010-08-31 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2010-08-31 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2010-08-31 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2011-08-01 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2013-02-01 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2013-02-01 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2012-01-05 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2012-01-05 |
| Conductivity Rate, Urea Nitrogen | LFP | Class 2 | Clinical Chemistry | No | 2012-01-05 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2012-01-05 |
| Ph Rate Measurement, Carbon-Dioxide | JFL | Class 2 | Clinical Chemistry | No | 2012-01-05 |
| Prealbumin, Fitc, Antigen, Antiserum, Control | DDS | Class 1 | Immunology | No | 2013-02-01 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 1996-04-29 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2012-10-31 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2012-10-31 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2012-10-31 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2012-10-31 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2012-10-31 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Titrimetric With Edta And Indicator, Calcium | CHW | Class 2 | Clinical Chemistry | No | 2012-10-31 |
| Radioimmunoassay, Methaqualone | KXS | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Hexane Extraction, Fluorescence, Vitamin E | JOB | Class 1 | Clinical Chemistry | No | 2012-10-31 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2012-10-31 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2012-10-31 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2012-10-31 |
| Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control | DDT | Class 2 | Immunology | No | 2012-10-31 |
| U.V. Method, Cpk Isoenzymes | JHW | Class 2 | Clinical Chemistry | No | 2012-10-31 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2012-10-31 |
| L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase | JGG | Class 1 | Clinical Chemistry | No | 2012-10-31 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2004-07-29 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2013-02-15 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2010-09-01 |
| Nephelometer, For Clinical Use | JQX | Class 1 | Clinical Chemistry | No | 2013-02-08 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2013-02-01 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2015-02-27 |
| Alcohol Control Materials | DKC | Class 1 | Clinical Toxicology | No | 2013-02-04 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-02-04 |
| Alpha-2-Macroglobulin, Antigen, Antiserum, Control | DEB | Class 2 | Immunology | No | 2013-02-01 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2006-07-24 |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | MGA | Class 1 | Immunology | No | 2011-08-02 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2014-11-17 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2001-09-27 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2013-02-06 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2019-01-31 |
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
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
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)
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
Glucose Oxygen Sensor
BUN 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
447020 IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
657365 SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum
476841 Lactate Dehydrogenase Reagent (LD 2 x 300)
442655 Lactate Dehydrogenase Reagent (LD 2 x 200)
442660 Lactate Dehydrogenase Reagent (LD-P 2 x 200)
A95550 Lactate Reagent (LACT 2 x 50)
SYNCHRON Lactate
OSR6127 LACTATE DEHYDROGENASE
OSR6227 LACTATE DEHYDROGENASE
447470 IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
474020 IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator
650038 Vigil HbA1c Controls Levels 1 & 2
475018 SYNCHRON Systems Methadone Reagent
A60298 Enzymatic Creatinine Reagent (CR-E 2 x 300)
447790 IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent
474630 IMMAGE Immunochemistry Systems CRPH High Sensitivity CRP Reagent
A71607 Amylase Reagent (AMY7 2 x 200)
SYNCHRON G7 Amylase Reagent
445990 Cannabinoid 100 ng Reagent (THC 1 x 150)
PerFix NC Kit (Fixative Reagent)
447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4
A28945 SYNCHRON Systems ISE Electrolyte Buffer
657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300)
UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG)
445865 SYNCHRON Systems Wash Concentrate II
472137 SYNCHRON and AU Systems Hemolyzing Reagent
447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1
Iris® System Cleanser Pack (800-3203)
447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3
447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2
598190 598190 Trace-Klean Ready to Use Cleaning Solution
447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2
589784 Trace-Klean Concentrated Cleaning Solution
A28937 SYNCHRON Systems ISE Electrolyte Reference
A88469 HbDIL DxC
iChem® VELOCITY Wash Solution Case of 2 x 7L (800-7217)
Iris® Diluent Pack (800-3202)
467826 Sample Diluent 1 DIL1
447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1
469110 Synchron Systems NO FOAM
447060 IMMAGE Immunochemistry Systems Wash Solution
445967 SYNCHRON CX Systems Antifoam
442831 PVT 2, 472055 PVT 5, 442830 PVT 3
DTCS Quick Start Kit
DNA Size Standard Kit - 400
DNA Size Standard Kit - 600
Separation Buffer
SEPARATION GEL-LPA I
CEQ Sample Loading Solution
Separation Gel LPAI
DNA Sequencing Separation Buffer
Sample Loading Solution (SLS)
DNA Size Standard Kit - 80
GenomeLab GeXP Start Kit
iQ Body Fluids Lysing Reagent (800-3213)
iQ Lamina 2 x 7L (800-3236)
iQ Body Fluids Conical Tubes (800-3215)
66039 Cleaning Solution
664090 CLENZ Solution
Access Wash Buffer II ( P/N: A16972 KY and DE MFG)
Access Substrate (P/N: 81906 MN MFG)
Flow Check Pro Fluorospheres
UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG)
Access Sample Diluent A (P/N: 81908 MN MFG)
FLOW-CHECK
Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG)
LumiPhos PRO Substrate (P/N: B96000 MN MFG)
DxFLEX Daily QC Fluorospheres
ODR2000 5L WASH SOLUTION
OSR62166 LIH
OSR0001 WASH SOLUTION
657197 Synchron AUTO-GLOSS CTS
B36415 Hemoglobin A1c Reagent (HbA1c3 250)
467942 Transferrin Reagent (TRFN 2 x 150)
SYNCHRON Transferrin
467925 Immunoglobulin G Reagent (Ig-G 2 x 150)
467920 Immunoglobulin A Reagent (Ig-A 2 x 150)
467930 Immunoglobulin M Reagent (Ig-M 2 x 150)
447690 IMMAGE Immunochemistry Systems MA Microalbumin Reagent
650182 Digoxin Reagent (DIGN 2 x 100)
447280 IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator
667710 Ultimate -D Bilirubin Control Level 1
667730 Ultimate -D Bilirubin Control Level 3
667720 Ultimate -D Bilirubin Control Level 2
667740 Ultimate -D Bilirubin Control Level 4
465440 Vigil Serology Control Level C
447710 IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent
445915 Synchron CX CRP Calibrator
465131 C-Reactive Protein Reagent (CRP 2 x 200)
475027 Propoxyphene Reagent (PROX 1 x 250)
465910, Synchron CX Calibrator 3
465909, Synchron CX Calibrator 2
465908, Synchron CX Calibrator 1
StatSpin CritSpin Digital Reader
446490 IMMAGE Immunochemistry Systems C4 Complement C4 Reagent
446450 IMMAGE Immunochemistry Systems C3 Complement C3 Reagent
475006 Opiate 2000 ng Reagent (OP2 1 x 250)
469945 SYNCHRON Systems DAT Drug Free Urine Control
969706 Direct LDL Cholesterol Reagent (LDLD 2 x 100)
663940 Immunochemistry Systems CAL 2 Calibrator 2
445811 SYNCHRON Systems 100 ng/mL THC Urine Calibrator
445814 SYNCHRON Systems 200 ng/mL THC Urine Calibrator
465912 SYNCHRON Systems 75 ng/mL THC Urine Control
465939 SYNCHRON Systems 125 ng/mL THC Urine Control
475030 Cannabinoid 50 ng Reagent (THC5 1 x 250)
445809 SYNCHRON Systems 50 ng/mL THC Urine Calibrator
465914 SYNCHRON Systems 20 ng/mL THC Urine Control
474947 Alcohol Reagent (ETOH 2 x 150)
474994 SYNCHRON Systems ETOH Calibrator
HbA1c Advanced
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device