FDA Registration Active 🇺🇸 United States

Beckman Coulter, Inc.

Reg #: 3008629785 · FEI: 3008629785 · Expires 2026
Products
5
Proprietary Names
104
Establishment Types
1
Classifications
5

Registration Details

Registration Name
Beckman Coulter, Inc.
Registration Number
3008629785
FEI Number
3008629785
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2295 Progress Dr., Suite C
City
Hebron
State
KY
ZIP
41048
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
Products, Red-Cell Lysing Products GGK
Diluent, Blood Cell GIF
Electrode, Ion Specific, Sodium JGS
General Purpose Reagent PPM
Detergent JCB

Proprietary Names

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) AQUIOS Sheath Solution DxFLEX Sheath Fluid ISOFLOW Sheath Fluid AcT 5diff Diluent DxH 500 Series Diluent (PN B36845) DxH Diluent DxH Concentrated ECO Diluent DxH ECO Diluent 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 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 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)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)