SCIMEDX CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2247139	1000122189	SCIMEDX CORP.	1	N	2020-04-25	53 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 GUDID	Product	Phone	Email
00813545023843	ProSorb-G 2 ml 50 Test - IgG Removal Reagent	18002215598	service@scimedx.com
00813545026905	MeDiCa - ANA (anti-nuclear) Rat Liver 48 Test Kit	18002215598	service@scimedx.com
00813545026912	MeDiCa - ANA (anti-nuclear) Rat Liver 96 Test Kit	18002215598	service@scimedx.com
00813545027322	MeDiCa - Multi-Ab III Mouse (Kidney + Stomach) 96 Test Kit	18002215598	service@scimedx.com

scimedx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
43497	1201845553	K994356	IMMUNOCYT	NBK	2000-02-23
43497	1820566924	K993034	MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD	MVM	1999-11-01
43497	1854534758	K992587	EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM	LSE	1999-12-22
43497	1394227503	K990916	INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY	KTL	1999-04-21
43497	1186575199	K990915	INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY	DHN	1999-04-21
43497	1296653633	K983886	POCKIT HSV 2 RAPID TEST	LGC	1999-08-19
43497	1359028392	K980638	ADI SYPHILIS RPR LIQUID CONTROLS	GMP	1998-07-06
43497	1661620679	K972873	IMMUSTRIP HAMA IGG	DAK	1998-03-17
43497	1253054156	K971591	INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)	LSQ	1998-03-13
43497	1019056966	K970198	IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES	DHN	1997-02-20
43497	1222776830	K962360	IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES	MOB	1996-09-30
43497	1954907066	K955085	HM-CAP EIA TEST (MODIFICATION)	LYR	1996-02-09
43497	1999163741	K954105	EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES	MOB	1996-03-19
43497	1163686087	K954062	EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES	MOB	1996-03-19
43497	2005794441	K953495	EIA KIT FOR THE DETECTION OF GBM ANTIBODIES	DBL	1996-04-10
43497	1866442255	K944159	HM-CAP EIA KIT	LYR	1995-07-18
43497	1021955209	K922297	INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST	KTN	1992-07-14
43497	1297727442	K922296	IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST	KTN	1992-07-14
43497	1550362874	K920569	INDXTM DIP-S-TICKSTM	LSQ	1993-02-09
43497	1497820087	K914953	IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY	LKI	1992-02-19
43497	1041903192	K910438	DIPSTICK SALMONELLA	GRM	1991-09-13
43497	1114642132	K905608	INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1	GQL	1991-11-07
43497	1357512504	K905409	EIA FOR DETECTION OF ANTIBODIES H. PYLORI	LYR	1991-06-10
43497	1564332886	K902237	MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT	DBL	1990-07-09
43497	1655782381	K901597	INDX DIP S TICKS	LSQ	1990-12-21
43497	1808857332	K900974	INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.	JRY	1990-04-16
43497	1185195214	K893873	SINGLE AND DUAL BAND DIPSTICK HCG TEST	DHA	1989-08-21
43497	1675512764	K892146	C REACTIVE PROTEIN LIQUID	DCK	1989-04-14
43497	1239014764	K892119	QUIK-DOT C REACTIVE PROTEIN	DCK	1989-04-14
43497	1742881159	K890048	QUIK-DOT TOXOPLASMOSIS	LLA	1989-06-09
43497	1280318364	K890025	QUIK-DOT ANTISTREPTOLYSIN-O	GTQ	1989-01-31
43497	1503893898	K884750	GROUP A STREP, BETA-STREP	GTZ	1988-12-22
43497	1548035539	K882835	INDIRECT FLUORESCENT ASSAY FOR (HCMV)	GQH	1988-12-05
43497	1741103981	K880478	PREGNANCY BETA-HCG CARD & LIQUID TEST	JHJ	1988-04-28
43497	1905387524	K880477	RPR TEST FOR SYPHILIS IN SERUM OR PLASMA	GMQ	1988-03-30
43497	2058847956	K880389	MERITEC(TM)-CAMPY (JCL)	LQP	1988-04-12
43497	1827498262	K880165	TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA	GMQ	1988-03-30
43497	1368871589	K880164	RF CARD TEST & RF LIQUID TEST	DHR	1988-02-10
43497	1660947049	K880163	PREGNANCY (HCG) CARD & LIQUID TEST	JHJ	1988-05-17
43497	1446234334	K880148	INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST	KTN	1988-02-10
43497	1146556278	K861362	IMMUNOMEDICS SERUM ELISA TEST SYSTEM	CZW	1986-06-06
43497	1562634927	K843343	MEDICA IIF-ANTI-THYROID ANTIBODY TEST	JZO	1984-10-22
43497	1906528159	K833636	ORTHO* SERUM ELISA TEST SYSTEM	DAK	1984-06-13
43497	1224861805	K832896	LEGIONELLA INDIRECT FLUORESCENT ANTIBOD	LHL	1983-10-14
43497	1970921665	K822066	LEGIONELLA PNEUMOPHILA	LHL	1982-09-21
43497	2046421501	K790759	IIF-APCA TEST KIT	DBJ	1979-07-30
43497	1761053748	K790430	MEDICA II-F-ASMA TEST KIT	DBE	1979-04-23
43497	1409832061	K790295	TEST KIT, IIF-AMA	DBM	1979-05-25
43497	1197600539	K790106	IIF-A-N-DNA TEST KIT	DHC	1979-03-15
43497	1928826601	K782048	TEST KIT, IIF-ANA	DHN	1979-01-17
43497	1378094860	K011348	PHASE II GBM IGG ANTIBODY EIA TEST	MVJ	2001-06-25
43497	1745024680	K011082	TPO IGG ANTIBODY EIA TEST	JZO	2001-06-06
43497	1803390860	K010289	SCIMEDX PHASE II MPO IGG ANTIBODY EIA	MOB	2001-03-07
43497	1754937832	K010287	SCIMEDX PHASE II PR3 IGG ANTIBODY EIA	MOB	2001-03-16
43497	1595941622	K002189	GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM	MST	2000-10-19
43497	1832432243	K002169	GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM	MST	2000-10-19
43497	1655864782	K002107	IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.	MVM	2000-08-04
43497	1833549409	K002024	PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA	GRY	2000-11-22
43497	1870822700	K001177	PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI	LYR	2000-11-13
43497	1018946309
43497	1032275393
43497	1065347815
43497	1074724818
43497	1086202571
43497	1168945763
43497	1222541798
43497	1251951825
43497	1253775235
43497	1292602928
43497	1403932354
43497	1413252009
43497	1436114755
43497	1442661425
43497	1474072090
43497	1523463619
43497	1534842732
43497	1615693186
43497	1617427824
43497	1835301440
43497	1848111769
43497	1868987287
43497	1901124189
43497	1927922131
43497	1931416673
43497	1937220774
43497	2031797427
43497	2058226325

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MOB	5	2001-03-16
LYR	4	2000-11-13
DHN	3	1999-04-21
LSQ	3	1998-03-13
KTN	3	1992-07-14
JZO	2	2001-06-06
MST	2	2000-10-19
MVM	2	2000-08-04
DAK	2	1998-03-17
DBL	2	1996-04-10
DCK	2	1989-04-14
JHJ	2	1988-05-17
GMQ	2	1988-03-30
LHL	2	1983-10-14
MVJ	1	2001-06-25
GRY	1	2000-11-22
NBK	1	2000-02-23
LSE	1	1999-12-22
LGC	1	1999-08-19
KTL	1	1999-04-21
GMP	1	1998-07-06
LKI	1	1992-02-19
GQL	1	1991-11-07
GRM	1	1991-09-13
JRY	1	1990-04-16
DHA	1	1989-08-21
LLA	1	1989-06-09
GTQ	1	1989-01-31
GTZ	1	1988-12-22
GQH	1	1988-12-05
LQP	1	1988-04-12
DHR	1	1988-02-10
CZW	1	1986-06-06
DBJ	1	1979-07-30
DBM	1	1979-05-25
DBE	1	1979-04-23
DHC	1	1979-03-15