FDA.reportPublic FDA data

Ina Hairston

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96806873003285777Ina Hairston1N2026-01-01841 Mountain Avenue Springfield NJ US 07081
30028006973002800697Ina Hairston1N2020-04-25841 Mountain Avenue Springfield NJ US 07081

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
65941763260373K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOB1998-02-17
65941865012900K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAMOB1998-02-17
65941505597719K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)CGJ1997-09-02
65941333986147K970932ORGENTEC MICRO-ALBUMIN EIA ASSAYJIR1997-04-08
65941771884232K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
65941253462025K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
65942027220665K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
65941433086398K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
65941925271307K962055ORGENTEC ANTI-SCL 70 ELISALJM1996-11-15
65941285456039K962054ORGENTEC ANTI-SS-A(RO) ELISALJM1996-11-15
65941727039563K962053ORGENTEC ANTI-JO-1 ELISALJM1996-11-15
65941987150551K962052ORGENTEC ABTI-SS-BB(LA) ELISALJM1996-11-15
65941804633438K955449ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYMID1996-05-23
65941973132134K955134ORGENTEC ENASCREEN ELISA ASSAYLLL1996-03-20
65942061173793K953671ORGEN TEC ANTI-DSDNA ELISA ASSAYLRM1995-11-09
65941256264181K952130ORGENTEC ANTI-TG ELISAJZO1995-06-20
65941483127527K952129ORGENTEC ANTI-TPO ELISAJZO1995-06-20
65941603889332K881125PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KITLIO1988-03-23
65942060674802K181473DENV Detect NS1 ELISAQCU2018-08-27
65941889395329K181017Free Testosterone AccuBind ELISA Test SystemCDZ2018-07-20
65941204314134K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELDJ2013-10-18
65941452228306K12336425OH VITAMIN D TOTAL ELISA TESTMRG2013-07-15
65941265394943K121046STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITPCG2012-12-20
65941300010437K111650IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...JJX2011-09-06
65941509118633K100499ORGENTEC RHEUMATOID FACTOR EIADHR2010-10-27
65941702906947K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEJLX2008-01-29
65941663663760K052649DRG SLV TESTOSTERONE ELISA TESTCDZ2006-01-27
65941640398640K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMLKJ2004-10-08
65941067302374K042248KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KITNST2004-12-17
65941093706885K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAJLS2004-07-22
65941168164945K040111ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEMMOB2004-04-05
65941333250254K030929ANA DETECTLJM2003-05-02
65942061388458K023483KALAZAR DETECTLOO2003-05-06
65941836450135K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119DCK2001-07-20
65941175695335K000043DRG AURICA ELISA TESTOSTERONE KITCDZ2000-04-17
65941016577358
65941109634960
65941112800661
65941167720263
65941179005928
65941216218325
65941254229894
65941278822684
65941281888826
65941299905102
65941318665550
65941338575309
65941367048042
65941384119992
65941405542178
65941411424128
65941413474313
65941443308515
65941448614979
65941487882085
65941502290260
65941522538738
65941547108627
65941570116549
65941573983343
65941581343951
65941584311673
65941587200909
65941588995289
65941604673252
65941606791165
65941613456471
65941663484517
65941666850074
65941728990061
65941732599805
65941732766218
65941779059676
65941789270778
65941795931239
65941801896901
65941807532394
65941888042463
65941890427546
65941898739957
65941914457269
65941956639228
65941993647466
65942025244668
65942038384816
65942045177768
65942055461761
491481278468788
491481471236185
491481777637138
491481919480627

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJM72003-05-02
CDZ32018-07-20
MOB32004-04-05
MID31996-10-10
JZO21995-06-20
QCU12018-08-27
LDJ12013-10-18
MRG12013-07-15
PCG12012-12-20
JJX12011-09-06
DHR12010-10-27
JLX12008-01-29
NST12004-12-17
LKJ12004-10-08
JLS12004-07-22
LOO12003-05-06
DCK12001-07-20
CGJ11997-09-02
JIR11997-04-08
LLL11996-03-20
LRM11995-11-09
LIO11988-03-23