Chembio Diagnostic Systems Inc

FDA Filings

This page includes the latest FDA filings for Chembio Diagnostic Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015417577
• FEI Number: 3015417577
• Name: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• Owner & Operator: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• Contact Address: 3661 HORSEBLOCK RD. --; MEDFORD NY 11763 US
• Official Correspondent:
  • THOMAS D IPPOLITO
  • x-631-9241135-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 555 Wireless Blvd --; Hauppauge, NY 11788 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 2431980
• FEI Number: 2431980
• Name: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• Owner & Operator: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• Contact Address: 3661 HORSEBLOCK RD. --; MEDFORD NY 11763 US
• Official Correspondent:
  • THOMAS D IPPOLITO
  • x-631-9241135-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3661 HORSEBLOCK RD. ; MEDFORD, NY 11763 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00607158000113 Chembio Diagnostic Systems Inc.	DPP Zika IgM Micro Reader 70-1064-0	2021-10-27
GUDID 00607158000083 Chembio Diagnostic Systems Inc.	DPP HIV-Syphilis	2021-01-06
GUDID 00607158000106 Chembio Diagnostic Systems Inc.	DPP Zika IgM System	2020-08-14
QKO CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP COVID-19 IgM/IgG System	2020-03-31
POG CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP Ebola Antigen System	2019-10-09
GUDID 00607158000076 Chembio Diagnostic Systems Inc.	Chembio HIV Reactive/Nonreactive Controls	2018-07-06
GUDID 00607158000069 Chembio Diagnostic Systems Inc.	Chembio SURE CHECK HIV 1/2 Assay	2018-07-06
GUDID 00607158000052 Chembio Diagnostic Systems Inc.	Chembio HIV 1/2 Stat-Pak Assay	2018-07-06
GUDID 00607158000045 Chembio Diagnostic Systems Inc.	Chembio DPP HIV 1/2 Rapid Test Control Pack	2018-07-06
GUDID 00607158000038 Chembio Diagnostic Systems Inc.	Clearview HIV Reactive/Nonreactive Controls	2018-07-06
GUDID 00607158000021 Chembio Diagnostic Systems Inc.	Clearview Complete HIV 1/2	2018-07-06
GUDID 00607158000007 Chembio Diagnostic Systems Inc.	Chembio DPP HIV 1/2 Assay	2018-07-06
PYS CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP Ebola Antigen System	2017-12-04
PYS CHEMBIO DIAGNOSTIC SYSTEMS, INC.	ANGELUS	2017-12-04
OSU CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP? Dengue NS1 Antigen Assay	2016-04-12
NWY CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP? Dengue IgM/IgG Assay	2016-04-12
EGN CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP Ebola Antigen System	2015-01-06
EGN CHEMBIO DIAGNOSTIC SYSTEMS, INC.	ANGELUS	2015-01-06
MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP HIV-Syphilis	2013-12-12
PMN BP120032 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP HIV 1/2 Assay	2013-11-21
PMN BP120032 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP HIV 1/2 Assay	2013-11-21
PMN BP050009 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	Test, HIV detection	2013-11-21
PMN BP050009 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	Test, HIV detection	2013-11-21
PMN BP050009 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	SURE CHECK HIV 1/2 Assay	2013-11-21
PMN BP050009 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	SURE CHECK HIV 1/2 Assay	2013-11-21
LIP CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP Syphilis Screen and Confirm	2009-12-02
PMN K981913 | LSR CHEMBIO DIAGNOSTIC SYSTEMS, INC.	Prevue B. burg. Antitbody Test	2007-12-10
PMN K841272 | GHM CHEMBIO DIAGNOSTIC SYSTEMS, INC.	Sickle STAT	2007-12-10
PMN BP050010 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	Chembio HIV 1/2 STAT PAK Assay	2007-12-10
PMN BP050010 | MZF CHEMBIO DIAGNOSTIC SYSTEMS, INC.	Chembio HIV 1/2 STAT PAK Assay	2007-12-10
MWB CHEMBIO DIAGNOSTIC SYSTEMS, INC.	HIV SURE CHECK	2007-12-10
MWB CHEMBIO DIAGNOSTIC SYSTEMS, INC.	HIV STAT PAK	2007-12-10
MWB CHEMBIO DIAGNOSTIC SYSTEMS, INC.	HIV DIPSTICK	2007-12-10
MWB CHEMBIO DIAGNOSTIC SYSTEMS, INC.	DPP HIV	2007-12-10
MWA CHEMBIO DIAGNOSTIC SYSTEMS, INC.	TB STAT PAK II	2007-12-10
MIU CHEMBIO DIAGNOSTIC SYSTEMS, INC.	Chagas STAT-PAK	2007-12-03
PMN K011551 Chembio Diagnostic Systems, Inc.	SURE CHECK PREGNANCY TEST	2001-08-14
PMN K010244 Chembio Diagnostic Systems, Inc.	SURE CHECK OVULATION PREDICTOR	2001-05-02
PMN K981913 Chembio Diagnostic Systems, Inc.	PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY	1999-02-12
PMN K961965 Chembio Diagnostic Systems, Inc.	SURE CHECK PREGNANCY TEST	1996-06-24
PMN K923925 Chembio Diagnostic Systems, Inc.	HCG STAT-PAK	1992-12-24

Related Finance Registrations

NCAGE Code	0JAD8	CHEMBIO DIAGNOSTIC SYSTEMS INC
NCAGE Code	31YL0	CHEMBIO DIAGNOSTIC SYSTEMS INC.
CAGE Code	0JAD8	CHEMBIO DIAGNOSTIC SYSTEMS INC
CAGE Code	31YL0	CHEMBIO DIAGNOSTIC SYSTEMS INC.
S.A.M. Registration	31YL0 [160348470]	CHEMBIO DIAGNOSTIC SYSTEMS INC.
DUNS	160348470	Chembio Diagnostic Systems Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082933159	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	TRANSFER PIPETTE	134 PKG
2018111718341	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SURE CHECK STAND	156 PKG