FDA.reportPublic FDA data

IMMUNOSTICS, INC.

Matched from indexed company URL: Immunostics, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22448212244821IMMUNOSTICS, INC.1Y2026-01-0138 Industrial Way E Ste 1 Eatontown NJ US 07724

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00722355002842Am I Pregnant? - Home pregnancy test for early results+1(856)727-0008info@acandcdistribution.com
00722355002859Am I Pregnant? - Home pregnancy test for early results+1(856)727-0008info@acandcdistribution.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
364721470220501K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
364721253554927K972606PREGNACOL PREGNANCY TESTJHJ1997-08-29
364721963350777K972457MONOCOL/LEX-IM TESTKTN1997-12-01
364721605070936K972456RHEUMACOL RHEUMATOID FACTOR TESTDHR1997-11-25
364721101212270K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
364721995707488K960174UNIMARK MIDSTREAM PREGNANCY TEST STICKLCX1996-04-01
364721026872801K941090UNISTEP HCG PREGNANCY TEST STRIPDHA1994-06-02
364721373318087K926569IMMUNO RA UNDILUTEDDHR1993-04-06
364721870774199K905782FHT (FECAL HEME TEST)KHE1991-05-06
364721774533857K902360HEMA-SCREENKHE1990-07-27
364721439111017K894780IMMUNO/ASOGTQ1989-10-16
364721389761650K880477RPR TEST FOR SYPHILIS IN SERUM OR PLASMAGMQ1988-03-30
364721505395926K861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISKTN1986-04-18
364721503254317K853105IMMUNO-IMKTN1985-09-03
364721635095413K842110SLIDE PREGNANCY TESTJHJ1984-07-12
364721454089898K834390IMMUNO-CRPDCN1984-02-03
364721252129006K821385SERO/TEX LE TESTDHC1982-05-28
364721535128149K182298hemochroma PLUS SystemGKR2018-11-16
364721208251813K171484hema-screen SPECIFIC GoldKHE2017-06-14
364721250897304K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE2017-01-17
364721797448708K163465hemochroma PLUS SystemGKR2017-09-08
364721719768003K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2016-05-23
364721570932259K061559ACON URINALYSIS REAGENT STRIPSCDM2006-08-11
364721178648664K060463HEMA SCREEN SPECIFIC IFOBTKHE2006-06-06
364721902195294K041728HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTEJHI2004-08-11
364722031658115K032992UNIMARK HOME PREGNANCY TEST DEVICELCX2003-11-21
364721989914199K022755LIFEGUARDKHE2002-09-24
364721019200492K013194UNIMARK HCG COMBO PREGNANCY TESTJHI2001-10-10
364721211192000K010582ACON STREP A RAPID TEST STRIPGTY2001-05-07
364721086801695
364721165795521
364721176086897
364721269649855
364721316039817
364721357060910
364721603097288
364721836661994
364721850985976
364721898844314
364722049131510
364721574503730
364722012228607

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KHE62017-06-14
KTN41997-12-01
GKR22018-11-16
JHI22004-08-11
LCX22003-11-21
DHR21997-11-25
JHJ21997-08-29
JXM12016-05-23
CDM12006-08-11
GTY12001-05-07
LYR11998-09-22
DHA11994-06-02
GTQ11989-10-16
GMQ11988-03-30
DCN11984-02-03
DHC11982-05-28

PMN#

GUDID#

hema-screen SPECIFIC GOLD - The hema-screen Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

Immunostics Company, Inc

2025-04-16

hema-screen SPECIFIC GOLD - The hema-screen Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

Immunostics Company, Inc

2025-04-16

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