Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015376545

FEI Number

3015376545

Entity Name

IMMCO DIAGNOSTICS, INC.

City/State/Country

Williamsville, NY, US

Establishment Address

10 Earhart Drive, --, Williamsville, NY 14221, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMMCO DIAGNOSTICS, INC. (Owner Number: 1315336)

Owner / Operator Contact Address

10 EARHART DR., --, Buffalo, NY 14221, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zenith ELITE ImmuGlo HEp-2 ELITE IFA Antinuclear Ab (Mouse Liver) Bartels; Bartels Viral Trans NEGATIVE CONTROL iSight ImmuLisa Anti-Native DNA Antibody Test ImmuLisa Skin Ab (Monkey/Guinea Pig Esoph) ImmuGlo Anti-GBM Antibody Kit Lyme B. burgdorferi (IgG) MarStripe Test Lyme B. burgdorferi (IgM) MarStripe Test Antinuclear Ab Test (HEP-2 Cells) Anti-Skin Ab (Monkey Esophaugus) MOUNTING MEDIUM ImmuLisa ImmuLisa Anti-Neutrophil Cytoplasmic ANCA Ab ImmuLisa Neuronal Antibody Strip Neuronal Antibody Tissue Substrate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2016-03-04
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2018-07-03
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2008-04-07
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2020-07-17
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	1992-07-08
IBK	Microscope, Fluorescence/U.V.	Pathology	Class 1	864.3600	2016-03-04
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2016-12-12
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-04-07
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2016-12-12
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2016-12-12
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2008-04-07
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	Class 2	866.5660	2019-06-24
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2017-02-03
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2017-10-31
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2008-04-07
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2008-04-07
KEQ	Media, Mounting, Water Soluble	Pathology	Class 1	864.4010	1992-07-08
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2016-12-12
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2016-12-12
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2008-04-08
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2016-12-12
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2011-08-31

Official Correspondent

Lee Kroening

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IMMCO DIAGNOSTICS, 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
3003212362	Nova Century Scientific	Burlington Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14
K880742	Inova Diagnostics, Inc.	NOVA LITE(TM) DSDNA	1988-03-25
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015376545. Last updated year: 2026. Please use registration number 3015376545 when referencing this establishment in official correspondence.