CHEMBIO DIAGNOSTIC SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2431980	2431980	CHEMBIO DIAGNOSTIC SYSTEMS, INC.	1	N	2026-01-01	3661 HORSEBLOCK RD. MEDFORD NY US 11763
3015417577	3015417577	CHEMBIO DIAGNOSTIC SYSTEMS, INC.	1	N	2020-04-25	555 Wireless Blvd -- Hauppauge NY US 11788

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
37259	1631896261	K981913	PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY	LSR	1999-02-12
37259	1047589688	K841272	SICKLE-STAT HEMOGLOBIN S SCREEN KIT	GHM	1984-04-13
37259	1223729752	K201256	Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge	DCK	2022-11-04
37259	1775969049	K200506	DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader	QFO	2020-06-03
37259	1520495084	DEN220023	Procise ADL	QYD	2023-09-29
37259	1874491930	DEN210056	Procise IFX	QXT	2023-09-29
37259	1612122346	BP180191
37259	2071783988	BP120032
228248	2071783988	BP120032
37259	1644858497	BP050010
228248	1644858497	BP050010
37259	1935880440	BP050009
228248	1935880440	BP050009
37259	1355693512
37259	1367097767
37259	1412910397
37259	1599258548
37259	1164800073
37259	1196863456
37259	1203501902
37259	1417634285
37259	1430810002
37259	1453912107
37259	1508808725
37259	1556428107
37259	1595865827
37259	1809922621

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
QYD	1	2023-09-29
QXT	1	2023-09-29
DCK	1	2022-11-04
QFO	1	2020-06-03
LSR	1	1999-02-12
GHM	1	1984-04-13

SURE CHECK PREGNANCY TEST
2001-08-14
Chembio Diagnostic Systems, Inc.
SURE CHECK OVULATION PREDICTOR
2001-05-02
Chembio Diagnostic Systems, Inc.
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
1999-02-12
Chembio Diagnostic Systems, Inc.
SURE CHECK PREGNANCY TEST
1996-06-24
Chembio Diagnostic Systems, Inc.
HCG STAT-PAK
1992-12-24
Chembio Diagnostic Systems, Inc.