FDA.reportPublic FDA data

Pauline Armstrong

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066069203006606920Pauline Armstrong1N2020-04-25515 INDUSTRIAL BLVD , KEARNEYSVILLE Kearneysville WV US 25430
30094731413009473141Pauline Armstrong1N2020-04-25515 INDUSTRIAL BLVD , KEARNEYSVILLE Kearneysville WV US 25430
30122305433012230543Pauline Armstrong1N2020-04-25515 INDUSTRIAL BLVD , KEARNEYSVILLE Kearneysville WV US 25430

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
98041118621972K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMMSJ2000-02-15
98041000489970K991576ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMCIX1999-06-30
98041030178974K984494RANDOX ALBUMINCIX1999-03-23
98041723354791K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
98042029138692K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
98041894519774K974607RANDOX CALCIUMCJY1998-02-02
98041653053841K974606RANDOX MAGNESIUMJGJ1998-02-12
98041803519196K974605RANDOX INORGANIC PHOSPHOROUSCEO1998-01-09
98041764058041K974604RANDOX IRONJMO1998-01-06
98041687590448K973995RANDOX BILIRUBINGIG1997-12-08
98041305189110K973993RANDOX CREATININECGX1998-03-06
98041122590769K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROLJJY1997-08-04
98041146428148K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KITDHR1997-09-09
98041095789950K971825PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TESTJFJ1997-07-24
98041617264246K970735BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROLLBS1997-06-06
98041563167068K970684LACTATE DEHYDROGENASE (LD)CFJ1997-05-07
98041329484951K961169RHEUMATOID FACTOR LATEX SLIDE TEST KITDHR1996-06-26
98041362600465K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORDEW1996-04-05
98041095316000K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORDFT1996-04-05
98041376225420K955794IGA IMMUNOTURBIDIMETRIC & CALIBRATORCZP1996-04-05
98042032068830K955087HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSLCP1996-06-13
98041901566635K954447C-REACTIVE PROTEIN LATEX KITDCK1995-12-18
98041412715296K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORDCK1995-07-31
98041998801670K953211AMYLASE (ETHYLIDENE PNGPG7) KITCIJ1996-06-21
98041301549672K953210GLUCOSE (HEXOKINASE) KITCFR1996-10-25
98041741146475K951223CK-MB (NAC-ACT)CGS1995-12-26
98041431286099K951222TOTAL PROTEIN (URINE)JIR1996-04-24
98041649698631K951221TOTAL CO2KHS1996-02-15
98041052535471K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
98041872776248K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
98041975052643K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDJJY1995-03-13
98041137537224K930104ACE CLINICAL CHEMISTRY SYSTEMJIX1993-08-23
98041722166384K923511CK-NAC ACTIVATED KITCGS1992-10-15
98041888295070K923510ALT (GPT) - ALANINE AMINOTRANSFERASECKA1992-11-16
98041438009303K923509GAMMA-GTJPZ1992-12-03
98042015610211K923508TRIGLYCERIDES GPO-PAPCDT1993-07-28
98041894705124K923507ALKALINE PHOSPHATASE KITCJE1992-12-03
98041922240135K923506UREA KITCDQ1993-09-27
98041757492662K923505AST (GOT) - ASPARTATE AMINOTRANSFERASECIT1992-11-16
98041916029492K923504CHOLESTEROL ENZYMATIC ENDPOINTCHH1994-01-10
98041829702951K923503URIC ACID ENZYMATIC COLORIMERIC KITKNK1993-07-22
98041282590160K882038GDS ENZYMATIC SALICYLATE REAGENTDKJ1988-06-24
98041976270691K881040EMIT VANCOMYCIN ASSAYLEH1988-04-19
98041678829167K880829GDS ENZYMATIC ACETAMINOPHEN REAGENTLDP1988-05-27
98041832695554K191454Atellica CH Amylase_2 (AMY_2)JFJ2019-07-30
98041413671270K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)NDY2018-05-25
98041777372635K162399Atellica CH Magnesium (Mg)JGJ2017-01-19
98041150202672K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX2016-11-15
98041070610203K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorCGS2016-09-07
98041633183949K153435Direct HDL Cholesterol (HDL)LBS2016-01-08
98041863352776K152344Total BilirubinJFM2016-01-28
98041945825934K152343Direct BilirubinJFM2016-02-16
98041973009873K152085Liquid CO2-2 (LCO2-2)KHS2016-02-24
98041948974370K150819TriglyceridesCDT2015-08-06
98041212336019K150654CholesterolCHH2015-09-29
98041019236395K142181RANDOX ALDOLASE CALIBRATION SERUMJIT2014-09-18
98041815870626K140971LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.JJY2014-12-08
98041490278324K140522RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROLJJY2014-05-22
98041097634252K140393RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3JJY2014-03-25
98041638857023K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTCDT2013-11-22
98041193913431K132156RANDOX CSF CONTROLS LEVELS 2 AND 3JJY2013-10-23
98041733458388K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2DLJ2013-08-08
98041076724026K131999HBA1C CONTROL, LEVEL 1 AND LEVEL 2JJX2013-07-26
98041709548611K131776ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3JJX2013-07-18
98041962659774K131554RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENTJJE2014-01-09
98041549828914K131307ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATORLCP2014-01-24
98041913405903K130337RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3JJY2013-06-19
98041292573404K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORCGS2013-11-21
98041604639131K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORJIX2013-01-14
98041819475415K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORDFC2012-12-20
98041047871297K122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORDDR2012-10-03
98041092894479K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORJIS2012-08-14
98041111561519K121907DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATORCJO2012-07-23
98041467335652K121746RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)JJX2012-07-11
98041225721426K121603RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3JJY2012-11-20
98041643239443K121588RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3JJX2012-06-20
98041423967116K113751RANDOX COCAINE METABOLITEDIO2012-05-08
98041234316153K113747RANDOX OPIATES ASSAYDJG2012-08-24
98041164770661K113720RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3JJY2012-09-20
98041609455830K112337RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVELJJY2011-12-01
98041904388638K110904RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3JJY2011-09-30
98041381767726K110874ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORJZG2012-01-20
98041271393545K110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2JJW2011-09-30
98041410351700K110736ADVIA CHEMISTRY FERRITIN (FRT) METHODDBF2011-08-17
98041835497293K110534RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3JJY2012-01-23
98041377206018K103701ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORSJIX2011-02-18
98041373744677K102346RANDOX DIGOXIN ASSAYKXT2011-10-14
98041624811658K101854ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429CFR2011-03-07
98041791636328K093384MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)JJY2010-03-10
98041920793747K092275RANDOX ECSTASY (MDMA) ASSAYDKZ2011-03-01
98042017566428K092274RANDOX BENZODIAZEPINE ASSAYJXM2010-10-15
98041040252582K092273RANDOX ETHANOL ASSAYDIC2010-11-01
98041238240249K092272RANDOX METHADONE ASSAYDJR2010-11-18
98041045888514K092269CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SETLDJ2011-04-08
98041363467612K092268RANDOX BARITURATES ASSAYDIS2011-05-25
98041269223922K092266RANDOX METHAMPHETAMINE ASSAYDKB2011-05-09
98041926062281K092258RANDOX METABOLITE (EDDP) ASSAYDJR2010-11-09
98041028956050K083906ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487NDY2009-03-11
98041440120447K083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)CJY2009-04-02
98041593983966K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100LPS2009-07-31
98041395009911K081294ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSNQD2008-07-29
98041910379448K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACJJY2008-06-02
98041156379577K072658ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORSDCN2008-04-01
98041815847769K072204ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORSJIX2007-10-05
98041894422240K063845ADVIA CHEMISTRY TOTAL BILIRUBIN_2JFM2007-12-07
98041691245332K063306ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72LCP2007-04-17
98041928786310K061056RANDOX LIQUID PROTEIN CALIBRATORJIX2006-07-20
98041449799540K053153RANDOX CALIBRATION SERUMJIX2006-01-13
98041050431144K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791JFM2005-12-30
98041207598659K052914RX IMOLACEM2006-03-31
98041764467669K050374ADVIA IMS LITHIUM ASSAYNDW2005-06-15
98041195296251K050179RANDOX BENZODIAZEPINE CLASS ASSAYJXM2005-05-17
98041819534665K043268SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2CEI2005-02-15
98041698744733K043267POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2CEJ2005-02-10
98041678726627K043266RANDOX URINE CONTROLSJJW2005-02-15
98041883085181K043071RANDOX PHENCYCLIDINE ASSAYLCM2005-01-27
98041737417363K042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITJJX2004-10-29
98041904772123K042015ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASECGA2004-09-29
98041261347150K041898CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMJJX2004-08-16
98041568874239K041361RANDOX TRI LEVEL CARDIAC CONTROLJJY2004-09-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY212014-12-08
JIX92013-01-14
JJX82013-07-26
LCP62014-01-24
CGS42016-09-07
JFM42016-02-16
CGA42004-09-29
LBS32016-01-08
CDT32015-08-06
JIS32012-08-14
DJR32010-11-18
DCK32000-08-04
JFJ22019-07-30
NDY22018-05-25
JGJ22017-01-19
CGX22016-11-15
KHS22016-02-24
CHH22015-09-29
DDR22012-10-03
DJG22012-08-24
DIO22012-05-08
KXT22011-10-14
JJW22011-09-30
DBF22011-08-17
DIS22011-05-25
DKB22011-05-09
LDJ22011-04-08
CFR22011-03-07
DKZ22011-03-01
JXM22010-10-15
CJY22009-04-02
JIF22003-05-12
JMO22000-05-02
CIX21999-06-30
DHR21997-09-09
JHN21995-09-15
JIT12014-09-18
JJE12014-01-09
DLJ12013-08-08
DFC12012-12-20