FDA.reportPublic FDA data

Microgenics Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30109398973010939897Microgenics Corporation1Y2026-01-0146500 Kato Road Fremont CA US 94538

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1722911279467821K984361ORAL-EZE ORAL FLUID COLLECTION SYSTEMPJD1999-01-13
1722911221611149K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYLFH1998-11-18
1722911817991335K983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSDKB1998-11-05
1722911319151704K981706AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2JIX1998-07-09
1722911945695959K980746CEDIA DAU EDDP ASSAYDJR1998-05-26
1722911420618901K972963MODIFIED CEDIA DAU PCP ASSAYLCM1997-09-22
1722912017632845K972526METHADONE EIA ASSAYDJR1997-08-04
1722911546526566K963840CEDIA PHENYTOIN II ASSAYDIP1996-11-20
1722911902919135K963306CEDIA N-ACETYLPROCAINAMIDE ASSAYLAR1996-10-29
1722911475632008K962795CEDIA DAU OPIATE 2K ASSAYDJG1996-10-30
1722911052236642K962269CEDIA CARDIAC TDM MULTI-CALSJIX1996-10-29
1722911865852275K962099CEDIA PROCAINAMIDE ASSAYLAR1996-08-27
1722911667336086K961659CEDIA CORE TDM MULTI-CALJIX1996-06-13
1722911614672096K961462CEDIA THEOPHYLLINE ASSAYKLS1996-06-27
1722911903630197K961393TRICYCLICS SERUM TOX ASSAYLFH1996-06-12
1722911019808190K961373ACETAMINOPHEN SERUM TOX EIA ASSAYLDP1996-07-08
1722911596811562K961372SERUM TOX CALIBRATORDKB1996-05-01
1722911022988260K960708BENZODIAZEPINE SERUM TOX EIA TESTJXM1996-05-20
1722911619987411K960664BARBITURATE SERUM TOX EIA ASSAYDIS1996-05-06
1722911871552830K960187COCAINE METABOLITE EIA TESTDIO1996-04-02
1722911787658269K955928BARBITURATE EIA ESSAY (MODIFICATION)DIS1996-03-11
1722911200187423K955814CEDIA DAU LSD ASSAYDLB1996-02-09
1722911138665296K954227CEDIA DAU METHADONE ASSAYDJR1995-11-17
1722911241135913K952596THEOPHYLLINE ENZYME IMMUNOASSAYKLS1995-08-11
1722911316410698K951133CEDIA DAU PROPOXYPHENE ASSAYJXN1995-05-02
1722911725601192K946210PHENOBARBITAL ENZYME IMMUNOASSAYDLZ1995-02-10
1722911405596499K945725PHENYTION EIA TESTDIP1995-02-03
1722912034743062K944703THYROXINE ENZYME IMMUNOASSAYKLI1994-12-09
1722911790848556K943998CANNABINOID EIA ASSAYLDJ1994-11-04
1722911263396130K943414PROPOXPHENE EIA TESTJXN1994-09-09
1722911622831400K943019CEDIA T4 MAB ASSAYKLI1994-10-20
1722911983420746K942436CEDIA DAU BARBITURATE ASSAYDIS1994-08-30
1722911348732529K942337CEDIA DAU MULTI-LEVEL THC ASSAYLDJ1994-08-01
1722911238277523K940935URINE CALIBRATORDKB1994-07-06
1722911129420411K940376QMS GENTAMICIN ASSAYLCD1994-06-02
1722911084587180K940123METHAQUALONE ENZYME IMMUNOASSAYKXS1994-05-03
1722912034295722K935904CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERSDIO1994-03-11
1722911088013938K935346CEDIA(R) DAU OPIATE ASSAYDJG1994-01-11
1722911694555858K935320PHENCYCLIDINE EIA ASSAYLCM1993-12-29
1722911648819740K932113CANNABINOID URINE CONTROLSJJX1993-06-29
1722911867141944K930734CEDIA VALPORIC ACID ASSAYLEG1993-09-21
1722911733340361K930529BENZODIAZEPINE ENZYME IMMUNOASSAYJXM1993-08-05
1722911594441607K924733ETHYL ALCOHOL CALIBRATORS & CONTROLDNN1992-12-09
1722911650514013K923783ETHYL ALCOHOL ASSAYDMT1993-01-21
1722911227092509K923386THC URINE CALIBRATORSDLJ1992-09-14
1722912020797496K914857CEDIA(R) CARBAMAZEPINE ASSAYKLT1992-01-15
1722911309163745K913470CEDIA(R) GENTAMICIN ASSAYLCD1991-09-27
1722911219679976K912143CEDIA(R) TOBRAMYCIN ASSAYLFW1991-07-26
1722911884291420K903101INNOFLUOR (TM) AMIKACIN CALIBRATOR SETDLJ1990-08-22
1722911826287755K896021CEDIA DIGITOXIN ASSAYLFM1989-11-08
1722911877723378K872644INNOFLUOR VANCOMYCIN CALIBRATOR SETDLJ1987-07-21
1722911682406772K872462INNOFLUOR(TM) GENTAMICIN CALIBRATOR SETDLJ1987-07-21
1722911500164846K872349INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SETDLJ1987-07-21
1722911664226467K853776MSI-HB HEMOGLOBIN CONTROLJPK1985-09-19
1722911217210513K243498Alinity c Benzodiazepines Reagent KitJXM2024-12-11
1722911878542069K240670DRI Ecstasy Plus AssayDKZ2024-10-30
1722911842013477K231020Alinity c Tricyclic Antidepressants Reagent KitLFH2023-11-17
1722911939333491K231007CEDIA Heroin Metabolite (6-AM) AssayDJG2023-09-27
1722912007510388K213875DRI TM Tricyclics Serum Tox AssayLFH2022-12-21
1722911826980953K211973DRI Cocaine Metabolite AssayDIO2021-09-24
1722911652399618K190968CEDIA Benzodiazepine AssayJXM2019-12-09
1722912005106851K181499DRI Cocaine Metabolite AssayDIO2018-07-06
1722911608913261K173963DRI Benzodiazepine AssayJXM2018-02-21
1722911462430531K173195DRI Hydrocodone AssayDJG2018-02-13
1722911269621292K173183CEDIA Heroin Metabolite (6-AM) AssayDJG2017-11-22
1722911972336540K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetDJG2017-04-06
1722911508294485K123518ABBOTT CARBAMAZEPINE ASSAYKLT2013-06-05
1722911120526465K123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSMLM2013-07-11
1722911602021145K123271ABBOTT PHENOBARBITAL ASSAYDLZ2013-04-26
1722911936495847K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYOUF2013-08-20
1722911279519168K103403MULTICONSTITUENT CALIBRATORJIX2011-02-04
1722911875447992K101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYDJG2011-04-08
1722911828269721K101753THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAYLAF2011-04-08
1722911590744324K101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYLCM2011-04-08
1722911363467369K101745THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAYDKZ2011-04-08
1722911185389658K101744THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAYLDJ2011-04-08
1722911660196935K101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYDIO2011-04-08
1722912018497590K093114THERMO SCIENTIFIC DRI AMPHETAMINES ASSAYDKZ2010-05-12
1722911256568186K090282QMS LIDOCAINEKLR2009-05-29
1722911577913971K081378DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLSDJR2009-01-14
1722911487656633K081083CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLSOAV2008-12-19
1722911716287995K080085MAS TOX CONTROLDIF2008-04-30
1722911222165050K070645SERADYN QMS TOPIRAMATENWM2007-05-17
1722911462910860K062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSORH2007-01-12
1722911057974935K060998QMS TOBRAMYCINLCR2006-07-21
1722911734662314K060709MULTIGENT GENTAMICINLCD2006-06-15
1722911381713316K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSLBZ2005-12-23
1722911735021312K052815QMS AMIKACIN REAGENTSKLQ2005-11-01
1722911827095200K051211QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLSNWM2005-11-18
1722911313651810K050419QMS VANCOMYCINLEH2005-04-01
1722911372264835K041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HJJX2004-08-16
1722911847464248K040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3JJY2004-04-28
1722911834705304K040758MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECTDIF2004-05-28
1722911373448251K040411DRI OXYCODONE ASSAYLAS2004-05-27
1722911680417741K040316CEDIA BUPRENORPHINE ASSAYDJG2004-06-23
1722911245373652K030649DRI COTININE EIA ASSAYMRS2003-05-22
1722911352015523K030405QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075LEG2003-04-28
1722911478343491K023617DRI METHADONE METABOLITE ENZYME IMMUNOASSAYDJR2003-08-27
1722911972140198K023208CEDIA CYCLOSPORINE PLUS ASSAYMKW2002-10-24
1722911603846863K023058QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEMKXT2002-10-24
1722911228876698K013995MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TLJJY2001-12-21
1722911271241187K012110DRI ECSTASY ENZYME IMMUNOASSAYDKZ2001-08-27
1722911908656961K012109DRI ECSTASY URINE CALIBRATORSDLJ2001-08-27
1722911189181507K011150DRIDAU OPIATE ASSAYDJG2001-06-20
1722911676901131K010496CEDIA DAU AMPHETAMINES/ECSTASY ASSAYLAF2001-05-29
1722911194650334DEN180030QMS Plazomicin ImmunoassayQDR2018-11-19
1722911353416690BK050061
1722911419259915BK040060
1722912012288892
1722912056775496
1722911037391326
1722911074703975
1722911107265232
1722911115462908
1722911129722907
1722911152096207
1722911229670120
1722911241614793
1722911317547493

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG92023-09-27
DLJ62001-08-27
JXM52024-12-11
DIO52021-09-24
JIX52011-02-04
DJR52009-01-14
DKZ42024-10-30
LFH42023-11-17
LCM32011-04-08
LDJ32011-04-08
LCD32006-06-15
DKB31998-11-05
DIS31996-05-06
KLT22013-06-05
DLZ22013-04-26
LAF22011-04-08
DIF22008-04-30
NWM22007-05-17
JJX22004-08-16
JJY22004-04-28
LEG22003-04-28
DIP21996-11-20
LAR21996-10-29
KLS21996-06-27
JXN21995-05-02
KLI21994-12-09
QDR12018-11-19
OUF12013-08-20
MLM12013-07-11
KLR12009-05-29
OAV12008-12-19
ORH12007-01-12
LCR12006-07-21
LBZ12005-12-23
KLQ12005-11-01
LEH12005-04-01
LAS12004-05-27
MRS12003-05-22
KXT12002-10-24
MKW12002-10-24

GUDID#

200 records. Showing 1-40. Next