Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019906

FEI Number

3019906

Entity Name

KENT LABORATORIES, INC.

City/State/Country

BELLINGHAM, WA, US

Establishment Address

777 Jorgensen Pl, BELLINGHAM, WA 98226, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KENT LABORATORIES, INC. (Owner Number: 3019906)

Owner / Operator Contact Address

777 JORGENSEN PLACE, --, Bellingham, WA 98226, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Radial Immunodiffusion Kit for Human IgA Antiserum to Human IgA Rhodamine Conjugated Antiserum to Human IgA Antiserum to Human Alpha 2 Macroglobulin Radial Immunodiffusion Test for Alpha 2 Macroglobulin Fluorescein Conjugated Antiserum to Human IgG (gamma chain specific) C-3 PROACTIVATOR (FACTOR B) Radial Immunodiffusion test for Alpha 1 Acidglycoprotein Antiserum to Human Alpha 1 Acidglycoprotein Rhodamine Conjugated Antiserum to Human IgD ANTISERUM TO PREALBUMIN Antiserum to Human Transferrin Radial Immunodiffusion Test for Human Transferrin Radial Immunodiffusion test for Human Prealbumin Antiserum to Human Prealbumin Radial Immmunodiffusion Test for Immunoglobulins (IgG,IgA, IgM) Antiserum to Human IgG, IgA and IgM Fluorescein Conjugated Antiserum to Goat IgG Peroxidase conjugated Antiserum, to Rabbit IgG Antiserum to Rabbit IgG Peroxidase Conjugated Antiserum to Goat IgG Antiserum to Goat IgG Fluorescein Conjugated Antiserum to Rabbit IgG Radial Immunodiffusion Kit for Human Prealbumin Antiserum to Human Transferrin Radial Immunodiffusion Kit for Human Transferrin Fluorescein Conjugated Antiserum to Human Kappa (free and bound) Radial Immunodiffusion Test for Human Haptoglobin ANTISERUM TO HAPTOGLOBIN Antiserum to Human Ferritin Peroxidase Conjugated Antiserum to Human IgA FITC CONJUGATED ANTI HUMAN ALBUMIN Antiserum to Human Kappa (free and bound) Radial Immunodiffusion Kit for Human C Reactive Protein Radial Immunodiffusion Test for Human Alpha 1 Antitrypsin Radial Immunodiffusion Test for Human C Reactive Protein Radial Immunodiffusion Test for Human C4 Radial Immunodiffusion Test for Human Transferrin Radial Immunodiffusion Test for Human Alpha 1 Acidglycoprotein Radial Immunodiffusion Test for Human IgA Radial Immunodiffusion Test for Human Haptoglobin Radial Immunodiffusion Test for Human C3 Proactivator (Factor B) Radial Immunodiffusion Test for Human Antithrombin III Radial Immunodiffusion Test for Human Apolipoprotein A1 Radial Immunodiffusion Test for Human Prealbumin Radial Immunodiffusion Test for Human IgD Radial Immunodiffusion Test for Human Apolipoprotein B Radial Immunodiffusion Test for Human C1q Radial Immunodiffusion Test for Human C5 Radial Immunodiffusion Test for Human C1 Esterase Inhibitor Radial Immunodiffusion Test for Human Alpha 2 Macroglobulin Radial Immunodiffusion Test for Human Ceruloplasmin Radial Immunodiffusion Test for Human C3 Radial Immunodiffusion Test for Human IgG Radial Immunodiffusion Test for Human IgM Fluorescein Conjugated Antiserum to Human IgD (delta chain specific) Rhodamine Conjugated Antiserum to Human Kappa ALPHA-1-ACID-GLYCOPROTEIN ANTISERUM Antiserum to Human IgG Radial Immunodiffusion Kit for Human IgG Fluorescein Conjugated Antiserum to Human Alpha 2 Macroglobulin Radial Immunodiffusion Kit for Human Ceruloplasmin Fluorescein Conjugated Antiserum to Human C1q Antiserum to Human C1q Radial Immunodiffusion Kit for Human C5 Radial Immunodiffusion Kit for Human Haptoglobin Fluorescein conjugated Antibody to Human C3b Inactivator (KAF) Antiserum to Human C3b Inactivator (KAF) Antiserum to Human C1 Esterase Inhibitor Antiserum to Human Properdin Fluorescein conjugated Antibody to Human Properdin FLUORESCEIN CONJUGATED AN Radial Immunodiffusion Test for Alpha 1 Antitrypsin Antiserum to Human Alpha 1 Antitrypsin WHOLE HUMAN SERUM ANTISERUM Fluorescein Conjugated Antiserum to Human IgM (mu chain specific) Antiserum to Human Fibrinogen Radial Immunodiffusion Test for Human Ceruloplasmin Antiserum to Human Ceruloplasmin Rhodamine Conjugated Antiserum to Human IgG antiserum to Human IgG (fab fragment specific) Fluorescein Conjugated Antiserum to Human IgA (alpha chain specific) Radial Immunodiffusion test for C-5 Antiserum to Human C-5 Peroxidase conjugated Antiserum to Human IgG FLUORESCEIN CONJUGATED Radial Immunodiffusion Kit for Human Alpha 1 Acidglycoprotein Radial Immunodiffusion test for C3 Proactivator (Factor B) Antiserum to C3 Proactivator (Factor B) Radial Immunodiffusion Kit for Human Alpha 2 Macroglobulin Radial Immunodiffusion Test for Human Apolipoprotein B Radial Immunodiffusion Test for Apolipoprotein A1 ANTI HUMAN HEMOPEXIN ANTISERUM HEMOPEXIN RADIAL I Radial Immunodiffusion Test for Human Hemopexin Radial Immunodiffusion Kit for Human Antithrombin III fluorescein Conjugated Antiserum to Human C-3 (b1c/b1a) Radial Immunodiffusion Test for Human C-4 Fluorescein Conjugated Antiserum to Human C-4 Antiserum to Human C4 Radial Immunodiffusion Test for Human Albumin Antiserum to Human Albumin Antiserum to Human IgD (delta chain) Radial Immunodiffusion for Human IgD Fluorescein Conjugated Antiserum to Human Fibrinogen FLUORESCEIN CONJUGATED ANTIS Antiserum to Human Myoglobin Antiserum to Human Lambda (free and bound) Fluorescein Conjugated Antiserum to IgE (epsilon chain specific) Antiserum to Human IgE FITC CONJUGATED ANT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
CZK	Iga, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2016-04-27
DGK	Igg, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
JZH	Factor B, Antigen, Antiserum, Control	Immunology	Class 2	866.5320	1992-12-15
DEX	Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2016-04-27
DGE	Igd, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2001-07-09
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2016-04-27
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2016-04-27
CGM	Method, Immunodiffusion, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2016-04-27
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2016-04-27
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2016-04-27
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2016-04-27
DEO	Kappa, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-04-27
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	1992-12-15
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2016-04-27
CZL	Iga, Peroxidase, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DDZ	Albumin, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	1992-12-15
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-04-27
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2016-04-27
JZQ	Plates And Equipment, Radial Immunodiffusion	Immunology	Class 1	866.4800	1992-12-15
DGG	Igd, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DEK	Kappa, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-04-27
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2001-07-09
DFZ	Igg (Gamma Chain Specific), Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DDY	Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2016-04-27
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Immunology	Class 2	866.5210	2016-04-27
DAK	Complement C1q, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-04-27
DAY	Complement C5, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-04-27
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2016-04-27
DHL	Protein, Complement, Antigen, Antiserum, Control	Immunology	Class 1	866.4100	2001-06-29
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2016-04-27
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2001-07-09
DFS	Igm, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-04-27
DAZ	Fibrinogen And Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7340	2016-04-27
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Immunology	Class 2	866.5210	2016-04-27
DFO	Igg, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DFK	Igg (Fab Fragment Specific), Antigen, Antiserum, Control	Immunology	Class 1	866.5520	1992-12-15
CZN	Iga, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DAY	Complement C5, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-04-27
DAA	Igg, Peroxidase, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DCB	Fab, Fitc, Antigen, Antiserum, Control	Immunology	Class 1	866.5520	2001-06-29
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2016-04-27
DAC	Complement C3b Activator, Antigen, Antiserum, Control	Immunology	Class 2	866.5260	2016-04-27
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2016-04-27
JHP	Radial Immunodiffusion, Lipoproteins	Clinical Chemistry	Class 1	862.1475	1992-12-15
CZX	Hemopexin, Antigen, Antiserum, Control	Immunology	Class 2	866.5490	1992-12-15
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2016-04-27
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-04-27
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-04-27
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2016-04-27
CZJ	Igd, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DAX	Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control	Hematology	Class 2	864.7340	2016-04-27
DBN	Fc, Antigen, Antiserum, Control	Immunology	Class 1	866.5530	2001-06-29
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2016-04-27
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-04-27
DGP	Ige, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-04-27
DBY	Fab, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 1	866.5520	1992-12-15

Official Correspondent

DONALD JORGENSEN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KENT LABORATORIES, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830580	Iagnon Corp.	DIAGNON FERRITIN 125 I RIA KIT	1983-05-05
K100538	Roche Diagnostics	TINA-QUANT FERRITIN GEN. 4	2010-06-22
K822676	Amico Lab, Inc.	FITC ANTISERA TO HUMAN IGG	1982-11-17
K860138	Sigma Diagnostics, Inc.	NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM	1986-03-28
K760034	Gamma Biologicals, Inc.	TEST, STREP, LATEX SLIDE	1976-08-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2009	Roche Diagnostics Corp.	2	Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in serum and plasma.
Z-0128-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
Z-0129-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Z-0130-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
Z-0002-2018	The Binding Site Group, Ltd.	2	Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

Similar Registrations

Registration Number	Establishment Name	Location
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3000148879	HORIBA ABX SAS	MONTPELLIER Herault, FR
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019906. Last updated year: 2026. Please use registration number 3019906 when referencing this establishment in official correspondence.