FDA.reportPublic FDA data

DIAGNOSYS LLC

Matched from indexed company URL: Diagnos Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12213631221363DIAGNOSYS LLC1N2026-01-0155 TECHNOLOGY DR STE 100 Lowell MA US 01851
20281901000125423DIAGNOSTIC MONITORING SOFTWARE1Y2026-01-011517 Church St Gardnerville NV US 89410
20293721000306617Diagnostic Automation/ Cortez Diagnostics Inc,.1Y2026-01-0121250 Califa St Suite 102 and 116 Woodland Hills CA US 91367
21132812113281DIAGNOSTIC GROUP LLC1Y2026-01-0110395 W 70th St EDEN PRAIRIE MN US 55344
22454512245451DIAGNOSTICA STAGO, INC.1Y2026-01-015 Century Dr PARSIPPANY NJ US 07054
29512801000221318Diagnostic Consulting Network, LLC.1N2026-01-013193 Lionshead Ave. Suite 200 Carlsbad CA US 92010
30062474213006247421DIAGNOSTICS FOR THE REAL WORLD, LTD.1N2026-01-01220 Vineyard Ct Ste 150 Morgan Hill CA US 95037
30070358843007035884DIAGNOSTIC BIOSYSTEMS1N2026-01-016616 Owens Drive Pleasanton CA US 94588
30091780483009178048DIAGNOSTICS DIRECT LLC1N2026-01-01373 96th St Unit C Stone Harbor NJ US 08247
30094223473009422347DIAGNOS INC.1N2026-01-017005 Taschereau Blvd. Suite 265 Brossard Quebec CA J4Z1A7
30211698693021169869DIAGNOSTIC SUPPORT SERVICES1N2026-01-013557 Butterfield Rd Ste 105 Aurora IL US 60502
30422436913042243691DIAGNOSTIC GREEN GMBH1N2026-01-01Feldkirchener Str. 7c, 85551 Kirchheim bei Munchen, Munich Bavaria DE 85551
22426742242674DIAGNOSTIC SPECIALTIES1N2020-04-254 LEONARD ST. Metuchen NJ US 08840
30052266013005226601DIAGNOSTICOS OCULARES,PUERTO RICO1Y2020-04-2521 Estancias De Cidra Cidra PR US 00739

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
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
3133541450892488K993033INTRAY GCJTY1999-12-16
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
128151945733023K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERJPA1998-11-12
500791449840935K983113BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KITCEP1998-11-18
89331317054311K983051AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERETY1998-11-18
89331410285103K983049AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTERETY1998-11-18
89331527778122K983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTEREWO1998-11-17
89331191807391K983046AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTERETY1998-11-17
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
89331719162443K974237GSI 70 AUDIOPATH SCREENEREWO1998-02-10
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
128151098937832K972144SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN IIIJBQ1997-07-25
500791875937575K972059QUIKPAC II ONE STEP COCAINE TESTDIO1997-08-28
500791874726219K971926QUIKSTRIP ONE STEP COCAINE TESTDIO1997-07-14
500791304459419K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISACFT1997-06-24
128151022150875K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)KQJ1997-10-09
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
128152039214982K971519ASSERACHROM TPA TEST KITGGP1997-08-19
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
128151537136050K964728STA-LIATEST D-DI TEST KITDAP1997-06-26
128151363400660K964716STA LIATEST CONTROL [N]+[P] KITGGN1997-06-26
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
128151635391912K963106CHROMOLIZE PAI-1 KITGGP1996-11-18
500791846359747K963002ACTIVE ANDROSTENEDIONE EIACIZ1996-08-16
128151112711062K962675STA - LIATEST VWF TEST KITGJT1996-10-25
128151095521045K962671STA-VWF CALIBRATOR KITGJT1996-09-13
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
128151845622950K961370LA POSITIVE CONTROL PLASMAGGC1996-05-24
500791363190525K961204MUMPS IGG TESTLJY1996-07-18
500791959919608K961053SERAQUEST RUBELLA IGGLFX1996-09-04
500791606941342K961012VZV IGG ELISA TEST SYSTEMLFY1996-07-24
500791151075047K960913ACCESS FREE T3 ASSAYCDP1996-03-29
128151773501132K960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)JBQ1996-08-14
500791481947176K960551DSL ACTIVE HUMAN GROWTH HORMONE ELISACFL1996-03-06
128152016016391K960438TINTELIZE PAI-1 KITGGP1996-06-05
500791589369040K960117PLATFORM ONESTEP PREGNANCY HOME TESTLCX1996-03-19
500791067926640K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
500791974613710K955895E. HISTOLYTICA TESTKHW1996-08-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GJT171996-10-25
JHI162022-01-31
GGP142001-06-06
JPA132026-04-27
EWO112018-05-11
ETY112015-07-15
DKZ102018-02-23
DJG82023-07-31
DAP82016-12-10
LLL81996-04-19
LJM81994-06-10
DIO72017-06-02
KFF72011-10-26
LCX72003-01-03
MID71998-06-02
GGN62014-12-12
LFX61998-10-16
LGD61997-10-21
MOB61997-04-10
LDJ52013-10-18
CEP52002-11-05
JBQ51997-07-25
CDZ42018-07-20
LIP42011-08-01
JIL42011-02-04
JLW42008-04-04
LFY42007-07-05
CGJ42005-11-30
JXM42001-05-29
LCM42001-05-29
CDP41999-06-02
LFZ41999-01-13
LLM41998-05-01
LSR41990-05-02
GJS32022-12-23
GWJ32020-04-24
KHE32018-02-15
GIR32006-12-06
GGC32006-07-28
MMI32006-03-02

PMN#

VIRTUE

2011-09-21

DIAGNOSOFT, INC.

CARA

2011-07-14

DIAGNOS, INC

200 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next