BECKMAN COULTER, INC.

Contract manufacturer · Miami, FL

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

2004Product codes first listed, by year (tallest: 4)2026

FDA registration: 1061932 (openFDA record; or search FDA's registration database)
FEI number: 3000203293
Registered for: FDA registration year 2026
Establishment types: Specification developer; Manufacturer; Contract manufacturer
Owner or operator: BECKMAN COULTER, INC. (FDA owner/operator no. 2050012)
Registered address: 11800 SW 147TH AVE., Miami, FL 33196
Contract listings: 9 device listings, 9 product codes, first listed Jul 29, 2004
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
GKG	Centrifuge, Hematocrit	Class II	Hematology	Contract manufacturing	Jun 1, 2015
IFB	Cytocentrifuge	Class I	Pathology	Contract manufacturing	Nov 17, 2014
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	Feb 23, 2015
JPI	Device, Hematocrit Measuring	Class II	Hematology	Contract manufacturing	Nov 17, 2014
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	Jul 29, 2004
JTC	Device, Microtiter Diluting/Dispensing	Class I	Microbiology	Contract manufacturing	Feb 24, 2015
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Class II	Microbiology	Contract manufacturing	Feb 23, 2015
OYE	Flow Cytometric Reagents And Accessories.	Class II	Hematology	Contract manufacturing	Dec 13, 2023
PWD	Flow Cytometric Test System For Hematopoietic Neoplasms	Class II	Hematology	Contract manufacturing	Dec 13, 2023