Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026565854

FEI Number

3026565854

Entity Name

Chembio Diagnostic Systems

City/State/Country

Bay Shore, NY, US

Establishment Address

1560 Fifth Avenue, Bay Shore, NY 11706, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

CHEMBIO DIAGNOSTIC SYSTEMS, INC. (Owner Number: 2431980)

Owner / Operator Contact Address

3661 HORSEBLOCK RD., --, MEDFORD, NY 11763, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Chembio HIV 1/2 STAT PAK Assay TB STAT PAK II DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader DPP® Dengue IgM/IgG Assay DPP HIV 1/2 Assay HIV STAT PAK HIV SURE CHECK HIV DIPSTICK DPP HIV Adalimumab Assay C-Reactive Protein, Antigen, Antiserum and Control DPP Ebola Antigen System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2009-12-02
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2007-12-10
MWA	System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex	Microbiology	Class 2	866.3372	2007-12-10
QFO	Zika Virus Serological Reagents	Microbiology	Class 2	866.3935	2020-08-03
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2020-08-03
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2020-08-03
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2021-11-03
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2021-11-03
NWY	Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies	Unknown	Class N	N/A	2016-04-12
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2013-11-21
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-11-03
MWB	Kit, Test, Saliva, Hiv-1&2	Unknown	Class 3	N/A	2007-12-10
MIU	Enzyme Linked Immunosorbent Assay, T. Cruzi	Microbiology	Class 1	866.3870	2007-12-03
QYD	Adalimumab Assay	Clinical Toxicology	Class 2	862.3115	2025-02-27
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2025-02-27
POG	Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid	Unknown	Class N	N/A	2019-10-09

Official Correspondent

THOMAS IPPOLITO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CHEMBIO DIAGNOSTIC SYSTEMS, 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
2431980	CHEMBIO DIAGNOSTIC SYSTEMS, INC.	MEDFORD, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191578	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control	2019-07-17
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026565854. Last updated year: 2026. Please use registration number 3026565854 when referencing this establishment in official correspondence.