CHEMBIO DIAGNOSTIC SYSTEMS, INC.

FDA Device Registration & Listing · MEDFORD, NY, US · Registration 2431980

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
2431980
FEI Number
2431980
Entity Name
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
City/State/Country
MEDFORD, NY, US
Establishment Address
3661 HORSEBLOCK RD., MEDFORD, NY 11763, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
CHEMBIO DIAGNOSTIC SYSTEMS, INC. (Owner Number: 2431980)
Owner / Operator Contact Address
3661 HORSEBLOCK RD., --, MEDFORD, NY 11763, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
BP180191

All Registered Proprietary Names

DPP Ebola Antigen System DPP® Dengue IgM/IgG Assay DPP® Dengue NS1 Antigen Assay TB STAT PAK II DPP HIV-Syphilis Chembio HIV 1/2 STAT PAK Assay Test, HIV detection SURE CHECK HIV 1/2 Assay DPP HIV 1/2 Assay C-Reactive Protein, Antigen, Antiserum and Control DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader Adalimumab Assay DPP HIV-Syphilis

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
POG Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid Unknown Class N N/A 2019-10-09
NWY Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies Unknown Class N N/A 2016-04-12
MIU Enzyme Linked Immunosorbent Assay, T. Cruzi Microbiology Class 1 866.3870 2007-12-03
OSU Dengue Serological Reagents Microbiology Class 2 866.3945 2016-04-12
MWA System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex Microbiology Class 2 866.3372 2007-12-10
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2013-12-12
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2007-12-10
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2013-11-21
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2009-12-02
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2021-11-03
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2013-11-21
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2021-11-03
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2025-02-27
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
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2021-11-03
QYD Adalimumab Assay Clinical Toxicology Class 2 862.3115 2025-02-27
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2020-12-09

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
3026565854 Chembio Diagnostic Systems Bay Shore, 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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3026565854 Chembio Diagnostic Systems Bay Shore, NY, US
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3005984081 LUMIQUICK DIAGNOSTICS, INC. SANTA CLARA, CA, US
3024753119 BOSTON EASY BIOTECH INC Andover, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2431980. Last updated year: 2026. Please use registration number 2431980 when referencing this establishment in official correspondence.
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