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QUIDEL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
30014613001782QuickVue+ - QkVue+ hCG S/U, 30T+1(858)552-1100technicalsupport@quidel.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
130861562715419K981373ALKPHASE-B ASSAY KITCIN1998-05-27
130861962011516K981364PYRILINKS-D ASSAY KITJMM1998-08-13
130861064319030K974111QUIDEL CH50 EQ EIADAE1998-07-29
130861264994394K952026PYRILINKS POLYCLONAL ASSAY KITJMM1995-11-03
130861650802483K941924ELVIS HSVGQN1995-05-01
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
130861393564664K181029Solana Bordetella Complete AssayOZZ2018-07-15
130861714510000K173250Solana GBS AssayNJR2017-12-21
130861381299075K171974Solana RSV+hMPV AssayOCC2017-10-16
130861429813148K170491Solana C. difficile AssayOZN2017-05-11
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
130862004609260K141173AMPLIVUE GAS ASSAYPGX2014-07-24
130861073553649K140029AMIPLIVUE HSV 1&2 ASSAYOQO2014-03-26
130862016370854K133503AMPLIVUE GBS ASSAYNJR2013-12-20
130861099712403K131813QUIDEL MOLECULAR RSV + HMPV ASSAYOCC2013-09-06
130861362411334K131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYOZE2013-08-29
130861152304741K123998QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAYOZN2013-03-08
130861301116619K12336425OH VITAMIN D TOTAL ELISA TESTMRG2013-07-15
130861011776998K123355AMPLIVUE C. DIFFICILE ASSAYOZN2012-12-13
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
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
130861569811594DEN140005LYRA DIRECT STREP ASSAYPGX2014-04-16
130861683425421DEN140004QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAYPGI2014-05-13
130861100626145
130861160248994
130861296159566
130861307449947
130861380343112
130861463018725
130861533989278
130861545264625
130861596247152
130861696180889
130861852843289
130861944605167
130862040439792

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCC42017-10-16
PGX42016-10-25
GNW42009-10-21
OZN32017-05-11
OMG32009-12-04
GQN32007-10-24
OZZ22018-07-15
NJR22017-12-21
PGI22016-11-28
OUY22016-08-15
JMM21998-08-13
DAK21988-08-04
OOU12014-10-09
OQO12014-03-26
OZE12013-08-29
MRG12013-07-15
JZO12010-05-18
GQS12009-12-23
GQL12009-08-28
LKT12008-12-23
LIN12008-06-13
LJP12007-09-24
GQW12007-08-30
DAE11998-07-29
CIN11998-05-27
CZY11987-11-25
DBA11987-07-23
MCB11984-05-21

PMN#

GUDID#

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