IMMUNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2244821	2244821	IMMUNOSTICS, INC.	1	Y	2026-01-01	38 Industrial Way E Ste 1 Eatontown NJ US 07724

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
36472	1470220501	K980798	BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST	LYR	1998-09-22
36472	1253554927	K972606	PREGNACOL PREGNANCY TEST	JHJ	1997-08-29
36472	1963350777	K972457	MONOCOL/LEX-IM TEST	KTN	1997-12-01
36472	1605070936	K972456	RHEUMACOL RHEUMATOID FACTOR TEST	DHR	1997-11-25
36472	1101212270	K961024	BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB	KTN	1997-02-04
36472	1995707488	K960174	UNIMARK MIDSTREAM PREGNANCY TEST STICK	LCX	1996-04-01
36472	1026872801	K941090	UNISTEP HCG PREGNANCY TEST STRIP	DHA	1994-06-02
36472	1373318087	K926569	IMMUNO RA UNDILUTED	DHR	1993-04-06
36472	1870774199	K905782	FHT (FECAL HEME TEST)	KHE	1991-05-06
36472	1774533857	K902360	HEMA-SCREEN	KHE	1990-07-27
36472	1439111017	K894780	IMMUNO/ASO	GTQ	1989-10-16
36472	1389761650	K880477	RPR TEST FOR SYPHILIS IN SERUM OR PLASMA	GMQ	1988-03-30
36472	1505395926	K861016	GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS	KTN	1986-04-18
36472	1503254317	K853105	IMMUNO-IM	KTN	1985-09-03
36472	1635095413	K842110	SLIDE PREGNANCY TEST	JHJ	1984-07-12
36472	1454089898	K834390	IMMUNO-CRP	DCN	1984-02-03
36472	1252129006	K821385	SERO/TEX LE TEST	DHC	1982-05-28
36472	1535128149	K182298	hemochroma PLUS System	GKR	2018-11-16
36472	1208251813	K171484	hema-screen SPECIFIC Gold	KHE	2017-06-14
36472	1250897304	K163554	hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test	KHE	2017-01-17
36472	1797448708	K163465	hemochroma PLUS System	GKR	2017-09-08
36472	1719768003	K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	JXM	2016-05-23
36472	1570932259	K061559	ACON URINALYSIS REAGENT STRIPS	CDM	2006-08-11
36472	1178648664	K060463	HEMA SCREEN SPECIFIC IFOBT	KHE	2006-06-06
36472	1902195294	K041728	HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE	JHI	2004-08-11
36472	2031658115	K032992	UNIMARK HOME PREGNANCY TEST DEVICE	LCX	2003-11-21
36472	1989914199	K022755	LIFEGUARD	KHE	2002-09-24
36472	1019200492	K013194	UNIMARK HCG COMBO PREGNANCY TEST	JHI	2001-10-10
36472	1211192000	K010582	ACON STREP A RAPID TEST STRIP	GTY	2001-05-07
36472	1086801695
36472	1165795521
36472	1176086897
36472	1269649855
36472	1316039817
36472	1357060910
36472	1603097288
36472	1836661994
36472	1850985976
36472	1898844314
36472	2049131510
36472	1574503730
36472	2012228607

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KHE	6	2017-06-14
KTN	4	1997-12-01
GKR	2	2018-11-16
JHI	2	2004-08-11
LCX	2	2003-11-21
DHR	2	1997-11-25
JHJ	2	1997-08-29
JXM	1	2016-05-23
CDM	1	2006-08-11
GTY	1	2001-05-07
LYR	1	1998-09-22
DHA	1	1994-06-02
GTQ	1	1989-10-16
GMQ	1	1988-03-30
DCN	1	1984-02-03
DHC	1	1982-05-28

PMN#

Hemochroma PLUS System
2018-11-16
Immunostics, Inc.
Hemochroma PLUS System
2017-09-08
IMMUNOSTICS, INC.
AFIAS IFOB With AFIAS-50
2017-08-08
IMMUNOSTICS, INC.
Hema-screen SPECIFIC Gold
2017-06-14
Immunostics, Inc.
Hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
2017-01-17
Immunostics, Inc.
HEMA SCREEN ER
2011-01-28
IMMUNOSTICS, INC.
HEMA SCREEN SPECIFIC IFOBT
2006-06-06
IMMUNOSTICS, INC.
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
2004-08-11
IMMUNOSTICS, INC.
RUBELLACOL
2003-07-16
IMMUNOSTICS, INC.
COLON ALERT TEST
1999-12-06
IMMUNOSTICS, INC.
MONOCOL/LEX-IM TEST
1997-12-01
IMMUNOSTICS, INC.
RHEUMACOL RHEUMATOID FACTOR TEST
1997-11-25
IMMUNOSTICS, INC.
PREGNACOL PREGNANCY TEST
1997-08-29
IMMUNOSTICS, INC.