Scimedx Corp

FDA Filings

This page includes the latest FDA filings for Scimedx Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2247139
FEI Number1000122189
NameSCIMEDX CORP.
Owner & OperatorSCIMEDX CORP.
Contact Address53 Richboynton Road
Dover NJ 07801 US
Official Correspondent
  • THOMAS - BRITTEN
  • x-973-6258822-13
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address53 Richboynton Rd
Dover, NJ 07801 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
SCIMEDX CORPORATION
PR3 IgG Test System PR33962023-06-21
SCIMEDX CORPORATION
MBO IgG Test System MBO3962023-06-21
SCIMEDX CORPORATION
GBM IgG Test System GBM3962023-06-21
SCIMEDX CORPORATION
ProSorb-G 2 ml 50 Test CB0042023-06-21
SCIMEDX CORPORATION
MeDiCa 8034-96-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8034-48-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8034-962020-12-09
SCIMEDX CORPORATION
MeDiCa 8034-482020-12-09
SCIMEDX CORPORATION
MeDiCa 8033-96-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8033-48-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8033-962020-12-09
SCIMEDX CORPORATION
MeDiCa 8033-482020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-400-M-RA2020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-400-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-200-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-96-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-48-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-400-NPBS2020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-200(4W)2020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-96-C22020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-48-C22020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-96-C12020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-48-C12020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-16002020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-4002020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-2002020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-962020-12-09
SCIMEDX CORPORATION
MeDiCa 8031-482020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-400-M-P-R2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-96-M-P2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-400-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-200-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-96-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-48-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-96-SD2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-962020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-2002020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-96-GI2020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-4002020-12-09
SCIMEDX CORPORATION
MeDiCa 8021-482020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-48-ESD-C12020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-96-TA2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-48-TA2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-96-MI2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-48-MI2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-96-ES2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-48-ES2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-400-ESD-R2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-96-ESD-R2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-400-ESD2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-96-ESD2020-12-09
SCIMEDX CORPORATION
MeDiCa 6001-48-ESD2020-12-09
SCIMEDX CORPORATION
MeDiCa 5001-48-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 5001-96-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 5001-962020-12-09
SCIMEDX CORPORATION
MeDiCa 5001-482020-12-09
SCIMEDX CORPORATION
MeDiCa 4001-96-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 4001-48-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 0842-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 0834-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 08342020-12-09
SCIMEDX CORPORATION
MeDiCa 0833-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 08332020-12-09
SCIMEDX CORPORATION
MeDiCa 0832-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 0831-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 08322020-12-09
SCIMEDX CORPORATION
MeDiCa 08312020-12-09
SCIMEDX CORPORATION
MeDiCa 0822-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 0821-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 08222020-12-09
SCIMEDX CORPORATION
MeDiCa 08212020-12-09
SCIMEDX CORPORATION
MeDiCa 0608-TA2020-12-09
SCIMEDX CORPORATION
MeDiCa 0604-TA2020-12-09
SCIMEDX CORPORATION
MeDiCa 0608-MI2020-12-09
SCIMEDX CORPORATION
MeDiCa 0604-MI2020-12-09
SCIMEDX CORPORATION
MeDiCa 0608-ESD2020-12-09
SCIMEDX CORPORATION
MeDiCa 0604-ESD2020-12-09
SCIMEDX CORPORATION
MeDiCa 0608-ES2020-12-09
SCIMEDX CORPORATION
MeDiCa 0604-ES2020-12-09
SCIMEDX CORPORATION
MeDiCa 0402-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 0401-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 04022020-12-09
SCIMEDX CORPORATION
MeDiCa 04012020-12-09
SCIMEDX CORPORATION
MeDiCa 0302-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 0301-M2020-12-09
SCIMEDX CORPORATION
MeDiCa 03022020-12-09
SCIMEDX CORPORATION
MeDiCa 03012020-12-09
SCIMEDX CORPORATION
MeDiCa 02022020-12-09
SCIMEDX CORPORATION
MeDiCa 02012020-12-09
SCIMEDX CORPORATION
MeDiCa 01022020-12-09
SCIMEDX CORPORATION
MeDiCa 01012020-12-09
SCIMEDX CORPORATION
EBV VCA IgG 10 wl; 10 pk I-EBV01X2019-02-21
SCIMEDX CORPORATION
EBV-VCA IgG 120 Test Kit I-EBV01G2019-02-21
SCIMEDX CORPORATION
ASA(ME)96 Test(L) 5396L2019-01-08
SCIMEDX CORPORATION
ASA(ME)48 Test(L) 5348L2019-01-08
SCIMEDX CORPORATION
P ESG Pack 8 WELL 53082019-01-08
SCIMEDX CORPORATION
P. ESG PACK 4 WELL 53012019-01-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORP.
The MeDiCa Line2018-08-08
SCIMEDX CORPORATION
L.pneu Gr.1(Mono)(HT) 18 Well 71052018-07-06
SCIMEDX CORPORATION
L.pneu 1-6(S) 18 Well(HT) 71012018-07-06
SCIMEDX CORPORATION
L.pneu 1-6(S) 6 Well Slide 70232018-07-06
SCIMEDX CORP.
IFA Anti-EMA (ME) IgA Assay (Endomysial Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-GBM (MK) IgG Assay (Glomerular Basement Membrane Antibody)2016-08-23
SCIMEDX CORP.
IFA Crithidia luciliae (Anti-nDNA)2016-08-23
SCIMEDX CORP.
IFA Anti-DNA (C. luciliae) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-TA (MT) IgG Assay (Thyroid Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-TA (MT) Automated IgG Assay (Thyroid Antibody)2016-08-23
SCIMEDX CORP.
IFA ANA (RL) IgG Assay (Antinuclear Antibody)2016-08-23
SCIMEDX CORP.
IFA ANA (MsL) IgG Assay (Antinuclear Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-MA (RK) IgG Assay (Mitochondrial Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-MA (MsK) IgG Assay (Mitochondrial Antibody)2016-08-23
SCIMEDX CORP.
IFA Autoscreen II (RL/RK/RS) IgG Automated Assay2016-08-23
SCIMEDX CORP.
IFA Autoscreen II (RL/RK/RS) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Autoscreen II (MsL/MsK/MsS) IgG Automated Assay2016-08-23
SCIMEDX CORP.
IFA Autoscreen II (MsL/MsK/MsS) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Autoscreen I (RK/RS) IgG Automated Assay2016-08-23
SCIMEDX CORP.
IFA Autoscreen I (RK/RS) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Autoscreen I (MsK/MsS) IgG Automated Assay2016-08-23
SCIMEDX CORP.
IFA Autoscreen I (MsK/MsS) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-Testes (M. Testes) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-Submaxillary (M. Submaxillary) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-Striated Muscle (R. Striated) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-Striated Muscle (M. Striated) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-Reticulin (RL/RK/RS) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-Reticulin (RL/RK/RS) IgA Assay2016-08-23
SCIMEDX CORP.
IFA Anti-Ovary (M. Ovary) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-ICA (MP) IgG Assay (Islet Cell Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-CMA (RH) IgG Assay (Cardiac Muscle Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-CMA (MH) IgG Assay (Cardiac Muscle Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-Adrenal (M. Adrenal) IgG Assay2016-08-23
SCIMEDX CORP.
IFA Anti-ASA (ME) IgG Assay (Anti-Skin Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-PCA (RS) IgG Assay (Parietal Cell Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-SMA (RS) IgG Assay (Smooth Muscle Antibody)2016-08-23
SCIMEDX CORP.
IFA Anti-SMA (MsS) IgG Assay (Smooth Muscle Antibody)2016-08-23
SCIMEDX CORP.
RBP ELISA ASSAY2016-08-23
SCIMEDX CORP.
uCyt+ 50 Test kit2013-01-23
SCIMEDX CORP.
Scimedx IFA Epstein-Barr Virus Early Antigen (EBV EA) IgG Assay2013-01-23
SCIMEDX CORP.
Scimedx IFA Crithidia luciliae (Anti-nDNA)2013-01-23
SCIMEDX CORP.
Scimedx IFA ANA HEp2 IgG Assay2013-01-23
SCIMEDX CORP.
Herpes Simplex Virus (HSV-2) QuickCard2013-01-23
SCIMEDX CORP.
DIP-S-TICKS: O. tsutsugamushi2013-01-23
SCIMEDX CORP.
Scanlisa H. pylori HM CAP IgG Assay2013-01-23
SCIMEDX CORP.
Scanlisa H. pylori HM CAP IgG Assay2013-01-23
SCIMEDX CORP.
ATI Infectious Mononucleosis Quik Dot Dry Card Test2013-01-23
SCIMEDX CORP.
ATI Infectious Mononucleosis IM Liquid Card Test2013-01-23
SCIMEDX CORP.
DIP-S-TICKS: R. typhi2013-01-23
SCIMEDX CORP.
Scimedx IFA Chlamydia trachomatis IgG Assay2013-01-23
SCIMEDX CORP.
ATI Dipstick Salmonella2013-01-23
SCIMEDX CORP.
Scimedx IFA Herpes Simplex Virus 2 (HSV-2) IgG Assay2013-01-23
SCIMEDX CORP.
Scimedx IFA Herpes Simplex Virus 1 (HSV-1) IgG Assay2013-01-23
SCIMEDX CORP.
Scanlisa H. pylori HM CAP IgG Assay2013-01-23
SCIMEDX CORP.
DIP-S-TICKS: RMSF2013-01-23
SCIMEDX CORP.
Scimedx IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Assay2013-01-23
SCIMEDX CORP.
ATI Quik-Dot Toxoplasmosis2013-01-23
SCIMEDX CORP.
ATI Group A Strep, Beta-Strep2013-01-23
SCIMEDX CORP.
Scimedx IFA Human Cytomegalovirus (HCMV) IgG Assay2013-01-23
SCIMEDX CORP.
ATI Pregnancy Beta-HCG Card and Liquid Test2013-01-23
SCIMEDX CORP.
Scimedx Latex Campy (jcl) Test kit2013-01-23
SCIMEDX CORP.
Trust RPR Test for Syphilis in Serum or Plasma2013-01-23
SCIMEDX CORP.
ATI RF Liquid Test2013-01-23
SCIMEDX CORP.
ATI RF Card Test2013-01-23
SCIMEDX CORP.
ATI Pregnancy (HCG) Card and Liquid Test2013-01-23
SCIMEDX CORP.
ATI Infectious Mononucleosis IM Card & Liquid Test2013-01-23
SCIMEDX CORP.
DIP-S-TICKS: Leptospira IgM2013-01-23
SCIMEDX CORP.
Scanlisa H. pylori PP CAP IgA Assay2013-01-23
SCIMEDX CORP.
Conjugate IFA Goat anti-h-IgM(?)-FITC with Eriochrome Black Counterstain2013-01-23
SCIMEDX CORP.
Conjugate IFA Goat anti-h-IgG+M+A(H&L)-FITC with Eriochrome Black Counterstain2013-01-23
SCIMEDX CORP.
Conjugate IFA Goat anti-h-IgG(H&L)-FITC with Eriochrome Black Counterstain2013-01-23
SCIMEDX CORP.
Conjugate IFA Goat anti-h-IgA-FITC with Eriochrome Black Counterstain2013-01-23
SCIMEDX CORP.
10% Normal Yolk Sac2013-01-23
SCIMEDX CORP.
Scimedx Taenia solium Antibody Assay2013-01-23
SCIMEDX CORP.
Scimedx Rickettsia typhi Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Rickettsia rickettsii Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Rickettsia prowazekii Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Rickettsia conorii Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx O. tsutsugamushi (Scrub typhis) Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Latex R. rickettsii (RMSF) Test Kit2013-01-23
SCIMEDX CORP.
Scimedx Ehrlichia chaffeensis Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Coxiella burnetii (Q fever) Antigen Slide2013-01-23
SCIMEDX CORP.
DIP-S-TICKS: Rickettsia conorii2013-01-23
SCIMEDX CORP.
DIP-S-TICKS: Q fever2013-01-23
SCIMEDX CORP.
Scimedx IFA Respiratory Syncytial Virus (RSV) IgG Assay2013-01-23
SCIMEDX CORP.
Scimedx Filaria Antibody Assay2013-01-23
SCIMEDX CORP.
Scimedx Legionella pneumophila Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Legionella longbeachae Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Entamoeba histolytica Antibody Assay2013-01-23
SCIMEDX CORP.
Scimedx Leptospira IgG Antibody Assay2013-01-23
SCIMEDX CORP.
DIP-S-TICKS: Salmonella typhi2013-01-23
SCIMEDX CORP.
Scimedx IFA Measles (Rubeola) IgG Assay2013-01-23
SCIMEDX CORP.
Scimedx IFA Mumps IgG Assay2013-01-23
SCIMEDX CORP.
Scimedx Arbovirus Antigen Slide2013-01-23
SCIMEDX CORP.
Scimedx Trichinella Antibody Assay2013-01-23
SCIMEDX CORP.
Scimedx Echinococcus Antibody Assay2013-01-23
SCIMEDX CORP.
Scimedx Diphtheria Antibody Assay2013-01-23
SCIMEDX CORP.
Scimedx Schistosoma Antibody Assay2013-01-23
SCIMEDX CORP.
Scimedx Toxocara Antibody Assay2013-01-23
SCIMEDX CORP.
Immustrip HAMA IgG2008-04-09
SCIMEDX CORP.
Scimedx IFA ANA (HEp2) IgG Assay2008-04-09
SCIMEDX CORP.
Scimedx IFA Anti-P-ANCA (Human Granulocyte) IgG Assay2008-04-09
SCIMEDX CORP.
Scimedx IFA Anti-C-ANCA (Human Granulocyte) IgG Assay2008-04-09
SCIMEDX CORP.
Scimedx EIA Kit for the Detection of Anti-PR3 Antibodies2008-04-09
SCIMEDX CORP.
Scimedx EIA Kit for the Detection of Anti-MPO Antibodies2008-04-09
SCIMEDX CORP.
Scimedx EIA Kit for the Detection of GBM Antibodies2008-04-09
SCIMEDX CORP.
ATI Single and Dual Band Dipstick HCG Test2008-04-09
SCIMEDX CORP.
ATI C. Reactive Protein Liquid Test2008-04-09
SCIMEDX CORP.
ATI Quik-Dot C.Reactive Protein2008-04-09
SCIMEDX CORP.
ATI Quik-Dot Anti-streptolysin-O2008-04-09
SCIMEDX CORP.
Scanlisa C3d IgG CIC Assay2008-04-09
SCIMEDX CORP.
Scanlisa C1q IgG CIC Assay2008-04-09
SCIMEDX CORP.
Scimedx IFA Anti-L. pneumophila Gr. 1-6 IgG Assay2008-04-09
SCIMEDX CORP.
Scimedx IFA Anti-L. pneumophila Gr. 1 IgG Assay2008-04-09
SCIMEDX CORP.
Scanlisa Anti-GBM IgG Assay2008-04-09
SCIMEDX CORP.
Scimedx TPO IgG Antibody EIA Test2008-04-09
SCIMEDX CORP.
Scanlisa Anti-MPO IgG Assay2008-04-09
SCIMEDX CORP.
Scanlisa Anti-PR3 IgG Assay2008-04-09
SCIMEDX CORP.
Scimedx Gliadin IgG Antibody EIA Detection2008-04-09
SCIMEDX CORP.
Scimedx Gliadin IgA Antibody EIA Detection2008-04-09
SCIMEDX CORP.
Scimedx IFA Anti-EMA(PUC) IgA Assay (Endomysial Antibody)2008-04-09
SCIMEDX CORP.
ATI Syphilis RPR Liquid Test2008-04-03
SCIMEDX CORP.
Wampole Impact RPR2008-04-03
SCIMEDX CORP.
ATI RPR Test for Syphilis in Serum or Plasma2008-04-03
SCIMEDX CORP.
Scimedx DFA Anti-L. pneumophila Gr. 1-6/bdglmj IgG Assay2008-03-28
SCIMEDX CORP.
Scimedx DFA Anti-L. pneumophila Gr. 1-6 IgG Assay2008-03-28
SCIMEDX CORP.
PHASE II GBM IGG ANTIBODY EIA TEST2001-06-25
SCIMEDX CORP.
TPO IGG ANTIBODY EIA TEST2001-06-06
SCIMEDX CORP.
EUROSPITAL EU-TTG IGA UMANA2001-04-24
SCIMEDX CORP.
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA2001-03-16
SCIMEDX CORP.
SCIMEDX PHASE II MPO IGG ANTIBODY EIA2001-03-07
SCIMEDX CORP.
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM2000-10-19
SCIMEDX CORP.
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM2000-10-19
SCIMEDX CORP.
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.2000-08-04
SCIMEDX CORP.
EU-TTG IGA ELISA2000-02-18
SCIMEDX CORP.
STREPTOLYSIN O REAGENT1999-12-06
SCIMEDX CORP.
ANTISTREPTOLYSIN - TITER1999-12-06
SCIMEDX CORP.
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES1997-02-20
SCIMEDX CORP.
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES1996-09-30
SCIMEDX CORP.
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES1996-04-10
SCIMEDX CORP.
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES1996-03-19
SCIMEDX CORP.
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES1996-03-19

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