FDA.reportPublic FDA data

DiaSorin Molecular LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20233652023365DiaSorin Molecular LLC1Y2026-01-0111331 Valley View St CYPRESS CA US 90630

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
20816101020243Rickettsia IFA IgG - IF0100G1-562-240-6500TS.Molecular@DiaSorin.com
20816101020250Rickettsia IFA IgM - IF0100M1-562-240-6500TS.Molecular@DiaSorin.com
20816101020342Q Fever IFA IgG - IF0200G1-562-240-6500TS.Molecular@DiaSorin.com
20816101020359Q Fever IFA IgM - IF0200M1-562-240-6500TS.Molecular@DiaSorin.com
20816101020397Arbovirus IFA IgG - IF0300G1-562-240-6500TS.Molecular@DiaSorin.com
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab Kit - NES44601-562-240-6500TS.Molecular@DiaSorin.com
20816101029062LIAISON NES® Group A Strep - NES28501-562-240-6500TS.Molecular@DiaSorin.com
20816101029079LIAISON NES® Group A Strep Control Swab Kit - NES28601-562-240-6500TS.Molecular@DiaSorin.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
252461557372733K993754HSV-1 ELISA IGG, MODEL EL0910GMXJ2000-02-09
252461628972947K993724HSV-2 ELISA IGG, MODEL EL0920GMYF2000-02-01
252461571414717K922374Q FEVER IGM IFA TESTGPJ1992-10-21
252461075099090K913906Q FEVER IGG IFA TESTGPJ1992-10-21
252461407603895K913618ARBOVIRUS IGM IFA TESTGQC1992-12-03
252462041287181K913617ARBOVIRUS IGG IFA TESTGQC1992-12-03
252461380677302K864110RICKETTSIAL IGG AND IGM IFA KITGPN1987-03-12
252461296930277K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitPGX2026-06-15
252461894483267K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)QOF2025-10-30
252461995260453K251978LIAISON NES FLU A/B, RSV & COVID-19QOF2025-12-23
252462032387995K220963Simplexa COVID-19 & Flu A/B DirectQOF2023-03-17
252461855400374K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackQDZ2022-11-05
252461661132607K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackOCC2020-08-22
252461390717858K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackPGI2019-11-26
252461036042575K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackPLO2019-05-13
252462015593760K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackNJR2018-11-07
252461704300095K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackOZZ2018-08-13
252461277011576K163085Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackOZN2017-02-14
252461833890780K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackOCC2015-09-21
252461336333436K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackOQO2015-08-28
252461137811977K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackPGX2015-03-18
252461614487850K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackOCC2014-12-05
252461705090881K120986STRATIFY JCV DXSELECTOYP2012-08-16
252461802457899K113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTOMN2012-04-04
252461400457680K1023143M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29
252461269146393K102170SIMPLEXA FLU A/B & RSVOCC2010-11-24
252462000781051K100148SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500OQW2010-05-24
252461958860710K040854WEST NILE VIRUS IGM CAPTURE ELISANOP2004-06-30
252461095298562K031953WEST NILE VIRUS ELISA IGG, MODEL EL0300GNOP2003-10-22
252461764289249K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GLGC2000-04-14
252461644229901DEN230092Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)SBT2024-07-15
252461735830834DEN130049SIMPLEXA HSV 1&2 DIRECTPGH2014-03-21
252461674454346
252461800404715
252461912706310
252461033690984
252461135845099
252461189548520
252461206087844
252461244189346
252461289510058
252461355481568
252461366453027
252461433981992
252461481289067
252461612470265
252461672375921
252461839319975
252461846624837
252461892445004
252461908453810
252461938183355
252462005920234
252462024226296
252462041555284
252462065220071

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCC42020-08-22
QOF32025-12-23
PGX22026-06-15
NOP22004-06-30
GQC21992-12-03
GPJ21992-10-21
SBT12024-07-15
QDZ12022-11-05
PGI12019-11-26
PLO12019-05-13
NJR12018-11-07
OZZ12018-08-13
OZN12017-02-14
OQO12015-08-28
PGH12014-03-21
OYP12012-08-16
OMN12012-04-04
OOI12010-10-29
OQW12010-05-24
LGC12000-04-14
MXJ12000-02-09
MYF12000-02-01
GPN11987-03-12

PMN#

GUDID#

111 records. Showing 1-40. Next