FDA Registration
Active
🇺🇸 United States
BECKMAN COULTER, INC.
Reg #: 2050010
·
FEI: 2050010
·
Expires 2026
Products
120
Proprietary Names
347
Establishment Types
1
Classifications
120
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2050010
- FEI Number
- 2050010
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2470 Faraday Ave
- City
- CARLSBAD
- State
- CA
- ZIP
- 92010
- Country
- US
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 |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2013-02-01 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2010-05-10 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 1996-04-29 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2011-12-30 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | 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 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2012-12-18 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2012-09-06 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2013-02-06 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2015-02-27 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2015-02-27 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2010-03-18 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2010-03-18 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Ph Rate Measurement, Carbon-Dioxide | JFL | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2013-02-04 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2013-02-01 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2011-08-01 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2004-07-29 |
| 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 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2010-09-01 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2022-03-29 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2011-12-30 |
| Ceruloplasmin, Antigen, Antiserum, Control | DDB | Class 2 | Immunology | No | 2013-02-01 |
| Antideoxyribonuclease, Streptococcus Spp. | GTR | Class 1 | Microbiology | No | 1983-09-27 |
| Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | LKL | Class 1 | Immunology | No | 2023-12-18 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2015-01-09 |
| 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 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2012-01-05 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2012-01-05 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2012-01-05 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2006-07-24 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2014-09-24 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2001-09-27 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2009-09-16 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2012-09-12 |
| 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 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2011-03-14 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2011-03-14 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2011-03-14 |
| Enzyme Immunoassay, Propoxyphene | JXN | 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 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 1977-12-16 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2011-12-30 |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2012-09-12 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2013-02-01 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2013-02-01 |
| Enzymatic Method, Bilirubin | JFM | Class 2 | Clinical Chemistry | No | 2016-02-17 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2013-02-01 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-02-01 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | MGA | Class 1 | Immunology | No | 2011-08-02 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2012-10-31 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2012-10-31 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2012-10-31 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | 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 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2012-10-31 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | 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 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | 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 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2012-10-31 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2012-10-31 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | 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 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | 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 |
| L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase | JGG | Class 1 | Clinical Chemistry | No | 2012-10-31 |
| Alpha-1-Antitrypsin, Antigen, Antiserum, Control | DEM | Class 2 | Immunology | No | 2011-08-02 |
| Prealbumin, Fitc, Antigen, Antiserum, Control | DDS | Class 1 | Immunology | No | 2013-02-01 |
| Alcohol Control Materials | DKC | Class 1 | Clinical Toxicology | No | 2013-02-04 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2010-04-29 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2011-12-30 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 1977-12-14 |
| Detergent | JCB | Class 1 | Pathology | No | 1977-12-14 |
| Factor B, Antigen, Antiserum, Control | JZH | Class 2 | Immunology | 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 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2013-02-06 |
| Alpha-2-Macroglobulin, Antigen, Antiserum, Control | DEB | Class 2 | Immunology | No | 2013-02-06 |
| 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 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2010-08-31 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2010-08-31 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2009-12-30 |
Proprietary Names
465440 Vigil Serology Control Level C
445850 Triglycerides Reagent (TG 2 x 300)
445915 Synchron CX CRP Calibrator
465131 C-Reactive Protein Reagent (CRP 2 x 200)
657365 SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum
475100 Microalbumin Reagent (MA 2 x 100)
476851 Lipase Reagent (LIP 2 x60)
467942 Transferrin Reagent (TRFN 2 x 150)
SYNCHRON Transferrin
445990 Cannabinoid 100 ng Reagent (THC 1 x 150)
475006 Opiate 2000 ng Reagent (OP2 1 x 250)
446440 IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent
446470 IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent
378194 Salicylate Reagent (SALY 2 x 45)
Synchron Salicylate test system
471080 SYNCHRON Systems Drug Calibrator 3 Plus
447630 IMMAGE Immunochemistry Systems TRF Transferrin Reagent
469630 SYNCHRON Systems Drug Calibrator 2
A15625 HDL Cholesterol Reagent HDL 2 x 200
B23634 UniCel DxC SYNCHRON Systems HDL Calibrator
SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2
Calcium Electrode
Glucose Oxygen Sensor
NA+ Electrode
BUN Electrode
Chloride Electrode
Potassium Electrode
CO2 Electrode
475089 SYNCHRON Systems MA Calibrator
469283 APO CAL Apolipoprotein Calibrator
969650 Pancreatic Amylase Reagent (PAM 2 x 60)
465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator
447450 IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent
474947 Alcohol Reagent (ETOH 2 x 150)
474994 SYNCHRON Systems ETOH Calibrator
465980 Vigil Lipid Control Level 2
469905 Vigil Lipid Control Level 1
465981 Vigil Lipid Control Level 3
465982 Vigil Lipid Control Level 4
OSR6119 GLUTAMYLTRANSFERASE (GGT)
OSR6219 GAMMA-GLUTAMYLTRANSFERASE (GGT)
A09426 Phosphorus Reagent (PHS 2 x300)
LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE -OXIDASE, HDL
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)
378045 SYNCHRON Systems Vancomycin Calibrator
474824 Vancomycin Reagent (VANC 2 x 100)
Total Immunoglobulin E (IgE) - C22529
445360 Magnesium Reagent (MG 2 x 100)
SYNCHRON Magnesium
469965 SYNCHRON Systems CAL 5 Plus
447720 IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent
447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent
447780 IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent
B24985 Glucose Reagent GLUH 2 x 300
441470 Immunochemistry Systems UCAL Urine Protein Calibrator
445824 Cannabinoid 20 ng Reagent (THC2 1 x 150)
464390 SYNCHRON Systems 20 ng/mL THC Urine Calibrator
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
UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon
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
A18298 Benzodiazepine Reagent (BNZG 1 x 250)
A71607 Amylase Reagent (AMY7 2 x 200)
SYNCHRON G7 Amylase Reagent
IRISpec CA/CB/CC Urine Chemistry Controls (800-7211)
iChemVELOCITY CalChek Kit (800-7703)
445860 Microprotein Reagent (M-TP 2 x 50)
SYNCHRON Micro Total Protein
969706 Direct LDL Cholesterol Reagent (LDLD 2 x 100)
A60298 Enzymatic Creatinine Reagent (CR-E 2 x 300)
439770 Ammonia Reagent (AMM 2 x 25)
Synchron AMM reagent and calibrators
Part numbers include, but are not limited to
A87905 Hemoglobin A1c Reagent (HbA1c- 400)
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)
475027 Propoxyphene Reagent (PROX 1 x 250)
465300 Immunochemistry Systems Level 2 Urine Protein Control
465290 Immunochemistry Systems Level 1 Urine Protein Control
OSR6165 HAPTOGLOBIN
988413 Haptoglobin Reagent (HPT 2 x 100)
QUANTIPLATE OR ENDOPLATE TM HA
476856 Direct Bilirubin Reagent (DBIL 2 x 300)
465915 SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
439715 Direct Bilirubin Reagent (DBIL 2 x 200)
442600 SYNCHRON Systems SYNCHRON Multi Calibrator
447690 IMMAGE Immunochemistry Systems MA Microalbumin Reagent
A38656 IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent
469975 CAL 5 PLUS Calibrator 5 Plus
Immage CAL 5 Plus
Immage CCRP reagent
446410 IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent
447730 IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent
467995 Valproic Acid Reagent (VPA 2 x 100)
467905 Apolipoprotein B Reagent (ApoB 2 x 100)
467900 Apolipoprotein A Reagent (ApoA 2 x 100)
469170 SYNCHRON Systems APO Calibrator
475081 SYNCHRON Systems PAB Calibrator
472472 Vigil TDM Control level 3
472467 Vigil TDM Control level 2
472461 Vigil TDM Control level 1
ENZYMATIC BILIRUBIN REAGENT
969620 C-Reactive Protein Reagent (C-RP 2 x 200)
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
447700 IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent
447710 IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent
683802 Enzymatic Bilirubin Reagent
447280 IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent
475106 Prealbumin Reagent (PAB 2 x 100)
442765 Albumin Reagent (ALB 2 x 300)
442820 Urea Reagent (UREA 2 x 300)
447740 IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent
447440 IMMAGE Immunochemistry Systems PAB Prealbumin Reagent
447020 IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
475003 Cocaine Metabolite Reagent (COCM 1 x 250)
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
465990 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 1
465996 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 3
465993 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 2
475009 Phencyclidine Reagent (PCP 1 x 250)
450125 Vigil Protein Control Level 2
450130 Vigil Protein Control Level 3
450120 Vigil Protein Control Level 1
474630 IMMAGE Immunochemistry Systems CRPH High Sensitivity CRP Reagent
Enzymatic Creatinine Reagent (CR-E 2 x 200)
465910, Synchron CX Calibrator 3
465909, Synchron CX Calibrator 2
465908, Synchron CX Calibrator 1
650182 Digoxin Reagent (DIGN 2 x 100)
474620 IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent
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)
447610 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
446460 IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
OSR6616 CHOLESTEROL
467825 Cholesterol Reagent (CHOL 2 x 300)
SYNCHRON Cholesterol
OSR6516 CHOLESTEROL
OSR6216 CHOLESTEROL
OSR6116 CHOLESTEROL
BECKMAN ENZYMATIC CH
445803 SYNCHRON Systems DAT Negative Urine Calibrator
475012 Barbiturates Reagent (BARB 1 x 250)
445930 SYNCHRON Systems Microprotein Calibrator
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
447460 IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
A40920 Creatinine Reagent (CR-S 2 x 300)
SYNCHRON Creatinine
Synchron Glucose
650218 SYNCHRON Systems Lipid Calibrator Levels 1 & 2
B36415 Hemoglobin A1c Reagent (HbA1c3 250)
450162 Vigil Serology Control Level 1
450163 Vigil Serology Control Level 2
450164 Vigil Serology Control Level 3
447470 IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
474020 IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator
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)
Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395067)
Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395261)
Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395066)
Hemoccult ICT Immunochemical Fecal Occult Blood Test Controls (PN 395068)
Hemoccult ICT Immunochemical Fecal Occult Blood Test Collection Cards (PN 395065)
Hemoccult SENSA Single Slides (PN A96636)
442785 Uric Acid Reagent (URIC 2 x 300)
SYNCHRON Uric acid
PerFix NC Kit (Lysing Reagent)
IRIS BODY FLUIDS LYSING REAGENT
AQUIOS Lysing Reagent Kit
Fixative Solution (10X)
OptiLyse C : Lysing Solution
Lysing Solution (10X)
IntraPrep
Reagent 2: Permeabilization
IOTest 3 Fixative
VersaLyse : Lysing Solution
IOTest 3 Lyse
DxH 500 Series Lyse (PN B36846)
Whole Blood Lysing Reagent
COULTER Rinsol Cleaning Agent
DxH Cell Lyse 1L & 5L
AcT 5diff Fix
DxH Retic Pack
IMMUNOPREP REAGENT
DxH diff Pack
AcT 5diff Hgb Lyse
COULTER DxH Cell Lyse
DxH ECO Cell Lyse (5L)
AcT 5diff WBC Lyse
Access Red Blood Cell Folate Lysing Agent
DxH ECO Cell Lyse (1L)
Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG)
378020 High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)
Synchron CRPH reagent
AQUIOS Sodium Hypochlorite Solution
AQUIOS Cleaning Agent (PN B25698)
DxH 500 Series Cleaner (PN 36868)
DxH Cleaner
AcT 5diff Rinse
Flow Clean (PN A64669)
CLENZ
AQUIOS Cleaning Agent (PN C48097)
Flow Clean (PN C48093)
447760 IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent
447070 IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent
475018 SYNCHRON Systems Methadone Reagent
449560 Immunochemistry Systems CAL 1 Calibrator 1
446480 IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator
441350 SYNCHRON Systems Enzyme Validator Set Levels 1 & 2
OSR6132 TOTAL PROTEIN
LIQUID - STAT TOTAL PROTEIN REAGENT
465986 SYNCHRON Systems Total Protein Reagent
OSR6170 URINARY/CSF PROTEIN
OSR6232 TOTAL PROTEIN
OSR6270 URINARY/CSF PROTEIN
OSR6632 TOTAL PROTEIN
AUH1011 ISE Buffer
AUH1018 Selectivity Check Na/K
AUH1016 High/Low Urine Standard
AUH1015 High Serum Standard
AUH1013 Reference Solution
AUH1014 Low Serum Standard
AUH1017 Internal Ref. Solution
AUH1012 Mid Standard
475000 Amphetamines Reagent (AMPH 1 x 250)
447750 IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent
663940 Immunochemistry Systems CAL 2 Calibrator 2
446490 IMMAGE Immunochemistry Systems C4 Complement C4 Reagent
446450 IMMAGE Immunochemistry Systems C3 Complement C3 Reagent
449730 Immunochemistry Systems CAL 3 Calibrator 3
447600 IMMAGE Immunochemistry Systems ALB Albumin Reagent
442640 Synchron Glucose 2 x 300 GLU Reagent
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)
472169 Acetaminophen Reagent (ACTM 100)
988462 C3 Reagent (C3 2 x 100)
988471 C4 Reagent (C4 2 x 100)
468405 SYNCHRON Systems CAL 1 Calibrator 1
475024 Opiate 300 ng Reagent (OP 1 x 250)
iQ Calibrator (800-3103)
iQ Controls/Focus Set (800-3104)
iQ Precision Kit (800-3014)
SYNCHRON Systems AQUA CAL 1, 2, 3
SYNCHRON Systems Creatinine Reagent
442745 Total Bilirubin Reagent (TBIL 2 x 300)
476861 Total Bilirubin Reagent (TBIL 2 x 400)
SYNCHRON Total Bilirubin
447790 IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent
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
447620 IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent
469165 Antistreptolysin-O Reagent (ASO- 2 x 100)
OSR6194 ASO
468429 IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator
447160 IMMAGE Immunochemistry Systems FER Ferritin Reagent
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)