BIO-RAD LABORATORIES, INC.

FDA Device Registration & Listing · Woodinville, WA, US · Registration 3007886270

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
3007886270
FEI Number
3008272466
Entity Name
BIO-RAD LABORATORIES, INC.
City/State/Country
Woodinville, WA, US
Establishment Address
8415 216th Street S.E., Woodinville, WA 98072, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BIO-RAD LABORATORIES, INC. (Owner Number: 3022521)
Owner / Operator Contact Address
8415 216th St SE, --, Woodinville, WA 98072, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
BK140112
PMA Number
N/A

All Registered Proprietary Names

BioPlex 2200 Reaction Vessel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2015-09-18

Official Correspondent

David Bhend

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIO-RAD LABORATORIES, 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
3032705 BIO-RAD LABORATORIES, INC. Woodinville, WA, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2014 Bio-Rad Laboratories 2
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Z-0027-2018 Hologic, Inc 2
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007886270. Last updated year: 2026. Please use registration number 3007886270 when referencing this establishment in official correspondence.
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