Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005592623

FEI Number

3005592623

Entity Name

WAVESENSE, INC.

City/State/Country

Irvine, CA, US

Establishment Address

15339 Barranca Pkwy, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WaveSense, Inc. dba nRichDX (Owner Number: 10034778)

Owner / Operator Contact Address

15339 Barranca Parkway, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blocking Buffer Anti-CD138 (B-A38) Antibody, paramagnetic Anti-URO-1 (J143) Anti-Urothelial (LBS8) Antibody, paramagnetic Anti-URO-1 (P1B5) Antibody, paramagnetic Anti-EpCAM (323/A3) Antibody, paramagnetic Debulking Buffer Revolution Sample Prep System Revolution System EpiSep NSD II (Neo-Magnetic Slide Dock) EpiSep NSD I (Neo-Magnetic Slide Dock) 15 mL Magnetic Tube Dock 5 mL Magnetic Tube Dock 2 mL Magnetic Tube Dock 50 mL Magnetic Tube Dock EpiSep MSD5 (Five Position Magnetic Slide Dock) EpiSep HS (Hybridization Slide)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2012-08-01
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2012-08-01
JCB	Detergent	Pathology	Class 1	864.4010	2012-08-01
JRB	Micro Mixer	Clinical Chemistry	Class 1	862.2050	2014-09-17
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2012-08-01
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2010-12-30

Official Correspondent

William Curtis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WaveSense, Inc. dba nRichDX

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3011715922	SUZHOU PULIKANG MEDICAL DEVICE CO LTD	Suzhou Jiangsu, CN
3015745029	Dongguan City Ruimi Gift Products Co Ltd	Dongguan Guangdong, CN
3008174888	NEWCOMER SUPPLY INC	Waunakee, WI, US
3004857344	Zhejiang Changdi Medical Co., Ltd.	JINHUA Zhejiang, CN
3006365273	RICCA CHEMICAL COMPANY LLC	BATESVILLE, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005592623. Last updated year: 2026. Please use registration number 3005592623 when referencing this establishment in official correspondence.