FDA.reportPublic FDA data

QUIDEL CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20246742024674QUIDEL CORP.1N2026-01-0110165 MCKELLAR CT. SAN DIEGO CA US 92121
30139820353013982035Quidel Cardiovascular Inc.1N2026-01-019975 Summers Ridge Road -- San Diego CA US 92121
15284501000122536QUIDEL CORPORATION1N2020-04-252005 East State Street, Suite 100 ATHENS OH US 45701

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
30014613201090QuickVue - QkVue hCG Urine 25T+1(858)552-1100technicalsupport@quidel.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
49952009966960K991747QUICKVUE ONE-STEP H. PYLORI II TESTLYR1999-08-04
49951439923327K991633QUICKVUE INFLUENZA A/B TESTPSZ1999-09-24
130861562715419K981373ALKPHASE-B ASSAY KITCIN1998-05-27
130861962011516K981364PYRILINKS-D ASSAY KITJMM1998-08-13
130861064319030K974111QUIDEL CH50 EQ EIADAE1998-07-29
49951607911887K974108SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)JJX1997-11-26
49951998083465K973858CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBOJHI1997-11-26
2117331682929525K973547TRIAGE STATMETERKHO1998-01-13
49951974659945K955108CARDS Q.S. STREP AGTZ1996-04-15
130861264994394K952026PYRILINKS POLYCLONAL ASSAY KITJMM1995-11-03
49951598135530K946276QUICKVUE(R) CHLAMYDIA TESTLJC1995-05-19
49951579980056K945080QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)GTY1995-02-10
130861650802483K941924ELVIS HSVGQN1995-05-01
49951544060854K934484QUICKVUE IN-LINE ONE-STEP STREP A TESTGTZ1994-07-18
49951538481624K931761QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)JJX1993-06-22
49951775964213K912868GROUP A STREP POSITIVE AND NEGATIVE CONTROLSGTZ1991-08-07
49951287608901K902510CARDS O.S. MONOKTN1990-07-16
130861682958682K882829CIRCULATING IMMUNE COMPLEXES CONTROLSDAK1988-08-04
130861879291602K874379CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAYCZY1987-11-25
130861282978482K872426CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYDBA1987-07-23
130861182445949K862649CYTOTECH CIC ENZYME IMMUNOASSAYDAK1986-09-04
130861866883014K833447CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-MCB1984-05-21
49951960466633K233688Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF2023-12-13
49952063093373K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentPGI2023-12-20
49951002413459K211342Sofia 2 Campylobacter FIALQP2021-11-23
2117332063760874K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProDKZ2019-06-19
130861393564664K181029Solana Bordetella Complete AssayOZZ2018-07-15
49951945629568K173496Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR2018-08-30
130861714510000K173250Solana GBS AssayNJR2017-12-21
130861381299075K171974Solana RSV+hMPV AssayOCC2017-10-16
130861429813148K170491Solana C. difficile AssayOZN2017-05-11
49951760041725K163713Sofia Lyme FIA, Sofia Lyme Control SetLSR2017-10-20
49951908495682K162911Sofia RSV FIA on Sofia 2 analyzerGQG2017-02-22
130861288519592K162451Solana HSV 1+2/VZV AssayPGI2016-11-28
130861220975170K162274Solana Strep Complete AssayPGX2016-10-25
130861669692416K161814Solana Influenza A+B AssayOCC2016-09-27
130861697220730K161182Solana Trichomonas AssayOUY2016-08-15
130861883004817K150868Solana GAS Assay, Solana instrumentPGX2015-06-23
130862028376118K143329AmpliVue Trichomonas AssayOUY2015-03-17
130861007638127K143206AmpliVue Bordetella AssayOZZ2014-12-10
130861827411841K141931LYRA ADENOVIRUS ASSAYOCC2014-10-09
130862040076054K141927LYRA PARAINFLUENZA VIRUS ASSAYOOU2014-10-09
49951209003132K141775SOFIA (R) STREP A+ FIAGTY2014-12-16
130862004609260K141173AMPLIVUE GAS ASSAYPGX2014-07-24
130861073553649K140029AMIPLIVUE HSV 1&2 ASSAYOQO2014-03-26
130862016370854K133503AMPLIVUE GBS ASSAYNJR2013-12-20
49951863938619K132066INFLAMMA DRYPFQ2013-11-21
130861099712403K131813QUIDEL MOLECULAR RSV + HMPV ASSAYOCC2013-09-06
130861362411334K131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYOZE2013-08-29
49951909300297K131166SOFIA(R) HCG FIAJHI2013-08-02
49951232386088K130398SOFIA(R) RSV FIAGQG2013-08-13
130861152304741K123998QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAYOZN2013-03-08
49951038408706K123793SOFIA STREP A FIAGTY2013-06-17
130861301116619K12336425OH VITAMIN D TOTAL ELISA TESTMRG2013-07-15
130861011776998K123355AMPLIVUE C. DIFFICILE ASSAYOZN2012-12-13
49951303453503K112177SOFIA ANALYZER AND INFLUENZA A+B FIAPSZ2011-10-24
49951233474112K110722RPS ADENO DETECTOR PLUSGOD2011-05-17
49951248354666K102175RAPIDVUE HCG TESTJHI2010-08-25
49951732054757K101918QUICKVUE RSV 10GQG2010-09-24
130861572113016K093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITGQS2009-12-23
130861356141288K093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITOMG2009-12-04
130861834009767K092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITGNW2009-10-21
130861990480108K092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITGNW2009-08-28
130861056513969K092229THYRETAIN TM TSI REPORTER BIOASSAYJZO2010-05-18
130861711095724K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMGQL2009-08-28
130861729375113K091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITOMG2009-09-11
130861438589140K090073D3 DFA METAPNEUMOVIRUS IDENTIFICATION KITOMG2009-03-06
130861822603291K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITLKT2008-12-23
130861117668083K081746D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITGNW2008-12-23
130861841009856K081164D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KITLIN2008-06-13
2117331468319331K072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5JJY2007-12-07
49951870455359K070747QUICK VUE RSV TEST, MODELS 20193, 20199GQG2007-04-23
130862062959700K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000GQN2007-10-24
130861003044329K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000GQW2007-08-30
130861709947775K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000GQN2007-09-21
130862034696341K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITLJP2007-09-24
130861893279864K061101D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITGNW2006-11-20
2117331059418255K060791TRIAGE TOX DRUG SCREEN, MODEL 94400DJR2006-06-22
2117332054568989K060788TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414DIF2006-07-10
49951651507803K053146QUICKVUE INFLUENZA A + B TESTPSZ2005-12-14
2117331591587659K052789TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200NBC2006-01-23
2117331378900482K051787TRIAGE BNP TEST, MODEL 98000XRNBC2005-09-22
2117331952996796K042890TRIAGE D-DIMER TEST, MODEL 98100GHH2004-11-29
2117331126641696K033383TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200NBC2003-12-23
2117332027673270K030286TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANELNBC2003-02-21
49951143165610K021423INSTANT-VIEW FECAL OCCULT BLOOD RAPID TESTKHE2002-06-17
2117331042091460K021317TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TESTNBC2002-07-01
49951447826851K020801QUICKVUE ONE-STEP HCG-COMBOJHI2002-05-17
49951113473703K020799QUICKVUE ONE-STEP HCG-URINEJHI2002-05-17
49951663088353K011097QUICKVUE DIPSTICK STREP AGTY2001-05-08
2117331726135162K000231TRIAGE BNP CALIBRATION VERIFICATION CONTROLSJJX2000-03-02
2117331035705017K000230TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLSJJX2000-02-29
49951851004634DEN220039Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQVF2023-03-08
130861569811594DEN140005LYRA DIRECT STREP ASSAYPGX2014-04-16
130861683425421DEN140004QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAYPGI2014-05-13
2117331050218868
130861100626145
130861160248994
2117331209163396
130861296159566

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GQG92017-02-22
JHI92013-08-02
GTY72014-12-16
PSZ52011-10-24
NBC52006-01-23
GTZ51996-04-15
OCC42017-10-16
PGX42016-10-25
GNW42009-10-21
JJX42000-03-02
PGI32023-12-20
LSR32018-08-30
OZN32017-05-11
OMG32009-12-04
GQN32007-10-24
KHE32002-06-17
QVF22023-12-13
OZZ22018-07-15
NJR22017-12-21
OUY22016-08-15
GOD22011-05-17
JMM21998-08-13
DAK21988-08-04
LQP12021-11-23
DKZ12019-06-19
OOU12014-10-09
OQO12014-03-26
PFQ12013-11-21
OZE12013-08-29
MRG12013-07-15
JZO12010-05-18
GQS12009-12-23
GQL12009-08-28
LKT12008-12-23
LIN12008-06-13
JJY12007-12-07
LJP12007-09-24
GQW12007-08-30
DIF12006-07-10
DJR12006-06-22

PMA#

PMN#

129 records. Showing 1-40. Next

GUDID#

122 records. Showing 1-40. Next