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#

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