FDA.reportPublic FDA data

Diagnostic Automation/ Cortez Diagnostics Inc,.

Matched from indexed company URL: Diagnostic Automation, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20293721000306617Diagnostic Automation/ Cortez Diagnostics Inc,.1Y2026-01-0121250 Califa St Suite 102 and 116 Woodland Hills CA US 91367

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 GUDIDProductPhoneEmail
00850049545433AccuDiag™ Prolactin (PRL) ELISA - AccuDiag™ Prolactin (PRL) ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of prolactin in a clinical specimen, using an enzyme immunoassay (EIA) method.8185913030onestep@rapidtest.com
00850049545723AccuDiag™ Insulin ELISA - AccuDiag™ Insulin ELISAA collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using an enzyme immunoassay (EIA) method.8185913030onestep@rapidtest.com
00850054026446AccuDiag™ T3 ELISA Kit - AccuDiag™ T3 ELISA KitA collection of reagents and other associated materials intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen, using an enzyme immunoassay.8185913030onestep@rapidtest.com
00850054026569QMedix™ - QMedix™ ANA Screen ELISA8185913030Onestep@rapdtest.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
500791075299884P990045DIASORIN ETI-AB-COREK PLUS ASSAY2001-03-30
500791243749048P990044DIASORIN ETI-CORE-IGMK PLUS ASSAY2001-03-30
500791066245807P990043DIASORIN ETI-EBK PLUS ASSAYLOM2001-02-08
500792043605140P990042DIASORIN ETI-AB-AUK PLUS ASSAY2001-03-30
500791231080686P990041DIASORIN ETI-AB-EBK PLUS ASSAY2001-03-30
500791898634282P990038DIASORIN ETI MAK-2 PLUS ASSAYLOM2001-03-30
500791693240473P890019AB -HAVKLOL1990-07-13
500791998601551P890014HA-IGMK AND ETI-HA-IGMKLOL1990-07-24
500791546098989P870048EBKLOM1990-07-13
500792005451941K994410INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TESTLDJ2000-06-21
500791489506269K994406INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TESTDJC2000-08-14
500791357413623K994405INSTANT-VIEW MARIJUANA URINE CASSETTE TESTDKE2000-06-02
500791710591302K994403INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TESTDIO2000-08-14
500791298783653K994400INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TESTDJC2000-08-04
500791316194161K994398INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TESTDIO2000-07-27
500791434393918K992748DRUGCHECK X MULTIDRUG SCREENING DEVICEDIO1999-09-02
500791906285621K992665MACRA LP(A) ENZYME IMMUNOASSAY KITDFC1999-11-26
500792044174582K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
500791145773252K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
500791892250999K991820HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODILYR1999-08-12
500791045703435K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
500791594884848K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.DDC1999-06-25
500791550620606K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
500791914971093K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
500791131514367K991179ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMDDC1999-06-17
500791183632738K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
500791776670614K990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICEDKZ1999-06-24
500791354629259K990207GLIADIN IGA ELISA TEST SYSTEMMST1999-03-26
500791958128201K990204GLIADIN IGG ELISA TEST SYSTEMMST1999-03-26
500792003471697K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400LOJ1999-06-21
500791153845763K984080INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TESTJHI1999-02-16
500791103565359K984079INSTANT-VIEW PREGNANCY URINE DIP-STRIP TESTJHI1999-02-16
500791288867284K984077INSTANT-VIEW PREGNANCY COMBO TESTJHI1999-02-16
500792055273120K984076INSTANT-VIEW PREGNANCY URINE TESTJHI1999-02-16
500791610807557K984075INSTANT-VIEW PREGNANCY URINE MID-STREAM TESTLCX1999-02-16
500791323467639K983656HSV-1 AND/OR -2 IGM ELISA TEST SYSTEMLGC1999-03-18
500791449840935K983113BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KITCEP1998-11-18
500791373337207K982485SERAQUEST CMV IGMLFZ1999-01-13
500791129037731K982315PROSPECT CAMPYLOBACTER MICROPLATE ASSAYLQP1998-11-18
500791152239463K982281SERAQUEST RUBELLA IGMLFX1998-10-16
500791072358844K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEJFH1998-09-15
500791473782803K981292QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TESTLCM1998-05-26
500791857494094K981120ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISALSE1998-08-21
500791485214328K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEMMID1998-06-02
500791132672098K981019QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TESTLCM1998-05-07
500791897809836K981014ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEMMID1998-06-02
500791204889755K980598EBNA-1 IGM ELISA TEST SYSTEMLLM1998-05-01
500791535088784K980349QUICKPAC II ONE STEP BARBITURATE TESTDIS1998-03-03
500791439618722K980088T-UPTAKE MICROPLATE EIAKHQ1998-02-04
500791304865323K974712QUIKSTRIP ONE STEP BARBITURATE TESTDIS1998-02-12
500791168797870K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISACEW1997-12-23
500791801156744K974060MINISTRIP/ SERUM AND URINE COMBO HCG TESTJHI1998-04-09
500791228692006K974059ONE STEP MIDSTREAM HCG PREGNANCY TESTLCX1998-04-09
500791206024239K974009PS-UNIT CASSETTE/SERUM AND URINE COMBO HCGJHI1998-03-13
500791085489024K973269QUIKSTRIP ONE STEP BENZODIAZEPINE TESTJXM1998-02-25
500791804882870K973243ACTIVE PSA ELISA (DSL-10-9700)LTJ1998-08-03
500791218970280K973196ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTSMID1997-10-29
500791529504558K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)CGJ1997-09-02
500791688202328K972571QUIKSTRIP ONE STEP OPIATES TESTDJG1997-08-20
500791018566248K972405QUIKPAC II ONE STEP OPIATE TESTDJG1997-08-08
500791987094995K972295SERAQUEST VZV IGGLFY1997-11-05
500791875937575K972059QUIKPAC II ONE STEP COCAINE TESTDIO1997-08-28
500791874726219K971926QUIKSTRIP ONE STEP COCAINE TESTDIO1997-07-14
500791304459419K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISACFT1997-06-24
500791292730809K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISADDC1997-07-03
500791224404757K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
500791778104540K971823ACTIVE TESTOSTERONE EIA (DSL-10-4000)CDZ1997-06-16
500791613237982K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
500791141928210K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
500791917818725K971709TOTAL THROXINE MICROPLATE EIA(225-300)KLI1997-06-16
500791661516824K971672SERAQUEST TOXOPLASMA IGMLGD1997-10-21
500791177804267K971585IMMUNOCARD STAT! ROTAVIRUSLIQ1997-08-20
500791336808473K971503MYCOPLASMA IGM ELISA TEST SYSTEMLJZ1997-08-20
500791924877142K971218QUIKSTRIP ONE STEP AMPHETAMINE TESTDKZ1997-05-30
500791629288216K971109QUIKPAC II ONE STEP AMPHETAMINE TESTDKZ1997-05-14
500791273702035K970724QUICKPAC II ONE STEP METHAMPHETAMINE TESTDKZ1997-05-13
500791642214534K970395QUIKSTRIP ONE STEP METHAMPHETAMINEDKZ1997-06-26
500791926063321K970250CLINISTRIPJIL1997-04-08
500791780930367K970150MYCOPLASMA IGG ELISA TEST SYSTEMLJZ1997-06-16
500791272437285K970149LEGIONELLA ELISA TEST SYSTEMLHL1997-06-18
500791521970977K964449ANCA SCREEN ELISA TEST SYSTEMMOB1997-04-10
500791854771439K964448PROTEINASE-3 IGG ELISA TEST SYSTEMMOB1997-04-10
500791913682134K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
500791708978144K964424ROTAVIRUS EIALIQ1997-08-08
500791050315981K963654QUIKSTRIP ONESTEP MARIJUANA (THC) TESTLDJ1997-02-28
500791261935382K963341MIDSTREAM ONESTEP PREGNANCY HOME TESTLCX1996-12-02
500791828845959K963207QUICKPAC II ONE STEP MARIJUANA (THC) TESTLDJ1997-02-20
500791471957653K963133PS-UNIT CASSETTE/SERUM HCGJHI1996-11-18
500791846359747K963002ACTIVE ANDROSTENEDIONE EIACIZ1996-08-16
500791278597258K962360IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESMOB1996-09-30
500791095660730K962019C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TESTDCK1996-11-25
500792064986859K962015RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TESTDHR1996-11-25
500791011913784K961765MPO ELISA TEST SYSTEMMOB1996-08-19
500791680584573K961764PR-3 ELISA TEST SYSTEMMOB1996-08-19
500791363190525K961204MUMPS IGG TESTLJY1996-07-18
500791959919608K961053SERAQUEST RUBELLA IGGLFX1996-09-04
500791606941342K961012VZV IGG ELISA TEST SYSTEMLFY1996-07-24
500791151075047K960913ACCESS FREE T3 ASSAYCDP1996-03-29
500791481947176K960551DSL ACTIVE HUMAN GROWTH HORMONE ELISACFL1996-03-06
500791589369040K960117PLATFORM ONESTEP PREGNANCY HOME TESTLCX1996-03-19
500791067926640K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
500791974613710K955895E. HISTOLYTICA TESTKHW1996-08-30
500791966177753K955603RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEMLLL1996-04-19
500791860784712K955114DSL AACTIVE DHEA EIA KITJKC1996-02-23
500791372374646K954977URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)JRE1996-03-11
500791325712465K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15
500791425208878K954191SERAQUEST CMV IGGLFZ1996-02-23
500791745158188K951705MINISTRIP HCGJHI1995-10-03
500791174444947K951549EBNA IGG EIA TEST SYSTEMLLM1996-04-29
500791421516338K951538BESURE ONE-=STEP HOME OVULATION PREDICTOR KITCEP1995-07-11
500791063110050K951363CARDIOLIPIN IGG,M,A EIA TEST SYSTEMMID1995-10-13
500791724546793K950169RIBOSOMAL P EIA TEST SYSTEMMQA1996-05-23
500791219765694K950104ELX800 AND EL800 AUTOMATED MICROPLATE READERSJJQ1995-03-21
500791105440468K946373MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEMGRZ1996-02-07
500792043687911K946217CARDIOLIPIN M EIA TEST SYSTEMMID1996-01-24
500791745541513K946216CARDIOLIPIN A EIA TEST SYSTEMMID1996-01-24
500791674261205K946215CARDIOLIPIN G EIA TEST SYSTEMMID1996-01-24
500791039939412K946122HEMAGEN ENA SCL-70 KIT (EIA METHOD)LLL1995-02-22
500791197836874K946121HEMAGEN ENA SS-A KIT (EIA METHOD)LLL1995-02-22
500791250685533K945951QUIKPAC II, ONE STEP HCG COMBO KITJHI1995-02-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JHI162022-01-31
DKZ102018-02-23
DJG82023-07-31
LLL81996-04-19
LJM81994-06-10
DIO72017-06-02
LCX72003-01-03
MID71998-06-02
LFX61998-10-16
LGD61997-10-21
MOB61997-04-10
LDJ52013-10-18
CEP52002-11-05
CDZ42018-07-20
JIL42011-02-04
JLW42008-04-04
LFY42007-07-05
CGJ42005-11-30
LCM42001-05-29
JXM42001-05-29
CDP41999-06-02
LFZ41999-01-13
LLM41998-05-01
LSR41990-05-02
KHE32018-02-15
MMI32006-03-02
KLI32003-08-22
DJR32002-11-22
DJC32002-11-13
LOM32001-03-30
LIP32000-11-29
DDC31999-06-25
LSE31998-08-21
JNL31997-07-03
GRZ31996-02-07
GTZ31995-08-30
DBM31994-05-03
DHN31990-01-02
MIU22016-12-16
MJH22007-03-15

GUDID#

102 records. Showing 1-40. Next