FDA.reportPublic FDA data

SCIMEDX CORP.

Matched from indexed company URL: SCIMEDX CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22471391000122189SCIMEDX CORP.1N2020-04-2553 Richboynton Rd Dover NJ US 07801

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
00813545023843ProSorb-G 2 ml 50 Test - IgG Removal Reagent18002215598service@scimedx.com
00813545026561MeDiCa - Rat Liver 4 Well Slide (each)18002215598service@scimedx.com
00813545026578MeDiCa - Rat Liver 8 Well Slide (each)18002215598service@scimedx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
434971201845553K994356IMMUNOCYTNBK2000-02-23
434971820566924K993034MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESDMVM1999-11-01
434971854534758K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMLSE1999-12-22
434971394227503K990916INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYKTL1999-04-21
434971186575199K990915INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODYDHN1999-04-21
434971296653633K983886POCKIT HSV 2 RAPID TESTLGC1999-08-19
434971359028392K980638ADI SYPHILIS RPR LIQUID CONTROLSGMP1998-07-06
434971661620679K972873IMMUSTRIP HAMA IGGDAK1998-03-17
434971253054156K971591INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)LSQ1998-03-13
434971019056966K970198IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIESDHN1997-02-20
434971222776830K962360IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESMOB1996-09-30
434971954907066K955085HM-CAP EIA TEST (MODIFICATION)LYR1996-02-09
434971999163741K954105EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIESMOB1996-03-19
434971163686087K954062EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIESMOB1996-03-19
434972005794441K953495EIA KIT FOR THE DETECTION OF GBM ANTIBODIESDBL1996-04-10
434971866442255K944159HM-CAP EIA KITLYR1995-07-18
434971021955209K922297INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TESTKTN1992-07-14
434971297727442K922296IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TESTKTN1992-07-14
434971550362874K920569INDXTM DIP-S-TICKSTMLSQ1993-02-09
434971497820087K914953IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYLKI1992-02-19
434971041903192K910438DIPSTICK SALMONELLAGRM1991-09-13
434971114642132K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1GQL1991-11-07
434971357512504K905409EIA FOR DETECTION OF ANTIBODIES H. PYLORILYR1991-06-10
434971564332886K902237MEDICA IIF ANTI-SKIN ANTIBODY TEST KITDBL1990-07-09
434971655782381K901597INDX DIP S TICKSLSQ1990-12-21
434971808857332K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.JRY1990-04-16
434971185195214K893873SINGLE AND DUAL BAND DIPSTICK HCG TESTDHA1989-08-21
434971675512764K892146C REACTIVE PROTEIN LIQUIDDCK1989-04-14
434971239014764K892119QUIK-DOT C REACTIVE PROTEINDCK1989-04-14
434971742881159K890048QUIK-DOT TOXOPLASMOSISLLA1989-06-09
434971280318364K890025QUIK-DOT ANTISTREPTOLYSIN-OGTQ1989-01-31
434971503893898K884750GROUP A STREP, BETA-STREPGTZ1988-12-22
434971548035539K882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)GQH1988-12-05
434971741103981K880478PREGNANCY BETA-HCG CARD & LIQUID TESTJHJ1988-04-28
434971905387524K880477RPR TEST FOR SYPHILIS IN SERUM OR PLASMAGMQ1988-03-30
434972058847956K880389MERITEC(TM)-CAMPY (JCL)LQP1988-04-12
434971827498262K880165TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMAGMQ1988-03-30
434971368871589K880164RF CARD TEST & RF LIQUID TESTDHR1988-02-10
434971660947049K880163PREGNANCY (HCG) CARD & LIQUID TESTJHJ1988-05-17
434971446234334K880148INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TESTKTN1988-02-10
434971146556278K861362IMMUNOMEDICS SERUM ELISA TEST SYSTEMCZW1986-06-06
434971562634927K843343MEDICA IIF-ANTI-THYROID ANTIBODY TESTJZO1984-10-22
434971906528159K833636ORTHO* SERUM ELISA TEST SYSTEMDAK1984-06-13
434971224861805K832896LEGIONELLA INDIRECT FLUORESCENT ANTIBODLHL1983-10-14
434971970921665K822066LEGIONELLA PNEUMOPHILALHL1982-09-21
434972046421501K790759IIF-APCA TEST KITDBJ1979-07-30
434971761053748K790430MEDICA II-F-ASMA TEST KITDBE1979-04-23
434971409832061K790295TEST KIT, IIF-AMADBM1979-05-25
434971197600539K790106IIF-A-N-DNA TEST KITDHC1979-03-15
434971928826601K782048TEST KIT, IIF-ANADHN1979-01-17
434971378094860K011348PHASE II GBM IGG ANTIBODY EIA TESTMVJ2001-06-25
434971745024680K011082TPO IGG ANTIBODY EIA TESTJZO2001-06-06
434971803390860K010289SCIMEDX PHASE II MPO IGG ANTIBODY EIAMOB2001-03-07
434971754937832K010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAMOB2001-03-16
434971595941622K002189GLIADIN IGG ANTIBODY EIA DETECTION SYSTEMMST2000-10-19
434971832432243K002169GLIADIN IGA ANTIBODY EIA DETECTION SYSTEMMST2000-10-19
434971655864782K002107IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.MVM2000-08-04
434971833549409K002024PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXAGRY2000-11-22
434971870822700K001177PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORILYR2000-11-13
434971018946309
434971032275393
434971065347815
434971074724818
434971086202571
434971168945763
434971222541798
434971251951825
434971253775235
434971292602928
434971403932354
434971413252009
434971436114755
434971442661425
434971474072090
434971523463619
434971534842732
434971615693186
434971617427824
434971835301440
434971848111769
434971868987287
434971901124189
434971927922131
434971931416673
434971937220774
434972031797427
434972058226325

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOB52001-03-16
LYR42000-11-13
DHN31999-04-21
LSQ31998-03-13
KTN31992-07-14
JZO22001-06-06
MST22000-10-19
MVM22000-08-04
DAK21998-03-17
DBL21996-04-10
DCK21989-04-14
JHJ21988-05-17
GMQ21988-03-30
LHL21983-10-14
MVJ12001-06-25
GRY12000-11-22
NBK12000-02-23
LSE11999-12-22
LGC11999-08-19
KTL11999-04-21
GMP11998-07-06
LKI11992-02-19
GQL11991-11-07
GRM11991-09-13
JRY11990-04-16
DHA11989-08-21
LLA11989-06-09
GTQ11989-01-31
GTZ11988-12-22
GQH11988-12-05
LQP11988-04-12
DHR11988-02-10
CZW11986-06-06
DBJ11979-07-30
DBM11979-05-25
DBE11979-04-23
DHC11979-03-15

PMN#

GUDID#

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