FDA.reportPublic FDA data

Quidel Cardiovascular Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30139820353013982035Quidel Cardiovascular Inc.1N2026-01-019975 Summers Ridge Road -- San Diego CA US 92121

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
30014613337706Triage - Triage BNP Reagents+1(858)552-1113technicalsupport@quidel.com
30014613337911Triage - Triage Cardiac Panel+1(858)552-1125technicalsupport@quidel.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2117331682929525K973547TRIAGE STATMETERKHO1998-01-13
2117332063760874K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProDKZ2019-06-19
2117331468319331K072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5JJY2007-12-07
2117331059418255K060791TRIAGE TOX DRUG SCREEN, MODEL 94400DJR2006-06-22
2117332054568989K060788TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414DIF2006-07-10
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
2117331042091460K021317TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TESTNBC2002-07-01
2117331726135162K000231TRIAGE BNP CALIBRATION VERIFICATION CONTROLSJJX2000-03-02
2117331035705017K000230TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLSJJX2000-02-29
2117331050218868
2117331209163396
2117332007668160
2117331006748925
2117331032266640
2117331105280898
2117331127656444
2117331138468478
2117331231072613
2117331438416836
2117331493371704
2117331545773181
2117331550941911
2117331636482329
2117331761625847
2117331813357538
2117331853942265
2117331928047847
2117331941672733
2117332021419207
2117332021532834
2117332053902381

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBC52006-01-23
JJX22000-03-02
DKZ12019-06-19
JJY12007-12-07
DIF12006-07-10
DJR12006-06-22
GHH12004-11-29
KHO11998-01-13

PMN#

GUDID#

43 records. Showing 1-40. Next