Data / Medical devices / United States / Chembio Diagnostic Systems, Inc.

Chembio Diagnostic Systems, Inc.: FDA-registered device maker in Medford, NY, United States, 4 510(k) clearances

Name: Chembio Diagnostic Systems, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Chembio Diagnostic Systems, Inc. is registered with the FDA (registration 2431980) in Medford, NY, United States. It lists 18 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 29, 2023. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2431980
Address: 3661 Horseblock RD., Medford, NY, United States, 11763
Owner or operator: CHEMBIO DIAGNOSTIC SYSTEMS, INC. (2431980)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export
First device listed: December 3, 2007
Registered through: 2027
Brand names listed: Adalimumab Assay, C-Reactive Protein, Antigen, Antiserum and Control, Chembio HIV 1/2 STAT PAK Assay, DPP Ebola Antigen System, DPP HIV, DPP HIV 1/2 Assay, DPP HIV-Syphilis, DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader and more

Devices it lists

Device	Product code	Class	Role	Source
Adalimumab Assay	QYD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antigens, Nontreponemal, All	GMQ	2	Manufacturer for export	accessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology Assays	QCH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Manufacturer for export	accessdata.fda.gov
Dengue Serological Reagents	OSU	2	Manufacturer for export	accessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Manufacturer for export	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Manufacturer for export	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, T. Cruzi	MIU	1	Manufacturer for export	accessdata.fda.gov
Infliximab Test System	QXT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Kit, Test, Saliva, Hiv-1&2	MWB	3	Manufacturer for export	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Manufacturer for export	accessdata.fda.gov
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid	POG	N	Manufacturer for export	accessdata.fda.gov
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex	MWA	2	Manufacturer for export	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Complaint file establishment, Manufacturer, Manufacturer for export	accessdata.fda.gov
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies	NWY	N	Manufacturer for export	accessdata.fda.gov
Zika Virus Serological Reagents	QFO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 29, 2023	DEN220023	Procise ADL	QYD	Unknown	Procisedx, Inc.	accessdata.fda.gov
September 29, 2023	DEN210056	Procise IFX	QXT	Unknown	Procisedx, Inc.	accessdata.fda.gov
November 4, 2022	K201256	Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge	DCK	Substantially Equivalent	Procise Diagnostics	accessdata.fda.gov
June 3, 2020	K200506	DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader	QFO	Substantially Equivalent	Chembio Diagnostic Systems	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 18, 2020	86098	Class II	Terminated	Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole	FDA revocation of the Emergency Use Authorization due to performance issues	accessdata.fda.gov
December 16, 2005	34263	Not yet classified	Terminated	Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled	Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.	accessdata.fda.gov
October 6, 2004	30288	Not yet classified	Terminated	OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated	Poor sealing of pouches and degradation of products. Firm received an from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.	accessdata.fda.gov

Compare with other makers

Updated September 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.