Beckman Coulter GmbH

FDA Device Registration & Listing · Krefeld North Rhine-Westphalia, DE · Registration 3002721051

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002721051
FEI Number
3002721051
Entity Name
Beckman Coulter GmbH
City/State/Country
Krefeld North Rhine-Westphalia, DE
Establishment Address
Europark Fichtenhain B 13, Krefeld North Rhine-Westphalia 47807, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BECKMAN COULTER, INC. (Owner Number: 2050012)
Owner / Operator Contact Address
250 S. Kraemer Blvd, --, Brea, CA 92821, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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) 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GGK Products, Red-Cell Lysing Products Hematology Class 1 864.8540 1977-12-14
PPM General Purpose Reagent Pathology Class 1 864.4010 2006-07-24

Official Correspondent

No official correspondent registered.

US Agent Details

Ian Pilcher Business: Beckman Coulter, Inc. Email: ipilcher@beckman.com Phone: (443) 3506459

Related Public Records

Same Entity

BECKMAN COULTER, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002721051. Last updated year: 2026. Please use registration number 3002721051 when referencing this establishment in official correspondence.
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