QUS-2 CALCANEAL ULTRASONOMETER
QUIDEL CORP.
QUIDEL CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2024674 | 2024674 | QUIDEL CORP. | 1 | N | 2026-01-01 | 10165 MCKELLAR CT. SAN DIEGO CA US 92121 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 4995 | 2009966960 | K991747 | QUICKVUE ONE-STEP H. PYLORI II TEST | LYR | 1999-08-04 |
| 4995 | 1439923327 | K991633 | QUICKVUE INFLUENZA A/B TEST | PSZ | 1999-09-24 |
| 4995 | 1607911887 | K974108 | SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) | JJX | 1997-11-26 |
| 4995 | 1998083465 | K973858 | CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO | JHI | 1997-11-26 |
| 4995 | 1974659945 | K955108 | CARDS Q.S. STREP A | GTZ | 1996-04-15 |
| 4995 | 1598135530 | K946276 | QUICKVUE(R) CHLAMYDIA TEST | LJC | 1995-05-19 |
| 4995 | 1579980056 | K945080 | QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS) | GTY | 1995-02-10 |
| 4995 | 1544060854 | K934484 | QUICKVUE IN-LINE ONE-STEP STREP A TEST | GTZ | 1994-07-18 |
| 4995 | 1538481624 | K931761 | QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) | JJX | 1993-06-22 |
| 4995 | 1775964213 | K912868 | GROUP A STREP POSITIVE AND NEGATIVE CONTROLS | GTZ | 1991-08-07 |
| 4995 | 1287608901 | K902510 | CARDS O.S. MONO | KTN | 1990-07-16 |
| 4995 | 1960466633 | K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | QVF | 2023-12-13 |
| 4995 | 2063093373 | K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | PGI | 2023-12-20 |
| 4995 | 1002413459 | K211342 | Sofia 2 Campylobacter FIA | LQP | 2021-11-23 |
| 4995 | 1945629568 | K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | LSR | 2018-08-30 |
| 4995 | 1760041725 | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | LSR | 2017-10-20 |
| 4995 | 1908495682 | K162911 | Sofia RSV FIA on Sofia 2 analyzer | GQG | 2017-02-22 |
| 4995 | 1209003132 | K141775 | SOFIA (R) STREP A+ FIA | GTY | 2014-12-16 |
| 4995 | 1863938619 | K132066 | INFLAMMA DRY | PFQ | 2013-11-21 |
| 4995 | 1909300297 | K131166 | SOFIA(R) HCG FIA | JHI | 2013-08-02 |
| 4995 | 1232386088 | K130398 | SOFIA(R) RSV FIA | GQG | 2013-08-13 |
| 4995 | 1038408706 | K123793 | SOFIA STREP A FIA | GTY | 2013-06-17 |
| 4995 | 1303453503 | K112177 | SOFIA ANALYZER AND INFLUENZA A+B FIA | PSZ | 2011-10-24 |
| 4995 | 1233474112 | K110722 | RPS ADENO DETECTOR PLUS | GOD | 2011-05-17 |
| 4995 | 1248354666 | K102175 | RAPIDVUE HCG TEST | JHI | 2010-08-25 |
| 4995 | 1732054757 | K101918 | QUICKVUE RSV 10 | GQG | 2010-09-24 |
| 4995 | 1870455359 | K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 | GQG | 2007-04-23 |
| 4995 | 1651507803 | K053146 | QUICKVUE INFLUENZA A + B TEST | PSZ | 2005-12-14 |
| 4995 | 1143165610 | K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | KHE | 2002-06-17 |
| 4995 | 1447826851 | K020801 | QUICKVUE ONE-STEP HCG-COMBO | JHI | 2002-05-17 |
| 4995 | 1113473703 | K020799 | QUICKVUE ONE-STEP HCG-URINE | JHI | 2002-05-17 |
| 4995 | 1663088353 | K011097 | QUICKVUE DIPSTICK STREP A | GTY | 2001-05-08 |
| 4995 | 1851004634 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | QVF | 2023-03-08 |
| 4995 | 1371145650 | ||||
| 4995 | 1212744400 | ||||
| 4995 | 1322508913 | ||||
| 4995 | 1461392921 | ||||
| 4995 | 1509075351 | ||||
| 4995 | 1525544052 | ||||
| 4995 | 1529656078 | ||||
| 4995 | 1751493941 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GQG | 9 | 2017-02-22 |
| JHI | 9 | 2013-08-02 |
| GTY | 7 | 2014-12-16 |
| PSZ | 5 | 2011-10-24 |
| GTZ | 5 | 1996-04-15 |
| LSR | 3 | 2018-08-30 |
| KHE | 3 | 2002-06-17 |
| QVF | 2 | 2023-12-13 |
| GOD | 2 | 2011-05-17 |
| JJX | 2 | 1997-11-26 |
| PGI | 1 | 2023-12-20 |
| LQP | 1 | 2021-11-23 |
| PFQ | 1 | 2013-11-21 |
| LYR | 1 | 1999-08-04 |
| LJC | 1 | 1995-05-19 |
| KTN | 1 | 1990-07-16 |
PMA#
QUS-2 (TM) CALCANEAL ULTRASONOMETER
QUIDEL CORP.
PMN#
QUIDEL MOLECULAR RSV + HMPV ASSAY
QUIDEL CORP.
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
QUIDEL CORP.
SOFIA(R) RSV FIA
QUIDEL CORP.
SOFIA(R) HCG FIA
QUIDEL CORP.
SOFIA INFLUENZA A+B FIA
QUIDEL CORP.
QUICKVUE INFLUENZA A+B
QUIDEL CORP.
QUIDEL MOLECULAR RSV + HMPV ASSAY
QUIDEL CORP.
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
QUIDEL CORP.
QUIDEL MOLECULAR INFLUENZA A+B
QUIDEL CORP.
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
QUIDEL CORP.
QUIDEL MOLECULAR HMPV ASSAY
QUIDEL CORP.
SOFIA ANALYZER AND INFLUENZA A+B FIA
QUIDEL CORP.
QUICKVUE RSV 10
QUIDEL CORP.
QUICKVUE INFLUENZA A+B TEST
QUIDEL CORP.
QUICK VUE RSV TEST, MODELS 20193, 20199
QUIDEL CORP.
QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
QUIDEL CORP.
QUICKVUE INFLUENZA A + B TEST
QUIDEL CORP.
QUICKVUE ADVANCE PH AND AMINES GLL TEST
QUIDEL CORP.
QUICKVUE INFLUENZA A+B TEST
QUIDEL CORP.
QUICKVUE ONE-STEP HCG-URINE
QUIDEL CORP.
QUICKVUE ONE-STEP HCG-COMBO
QUIDEL CORP.
QUICKVUE DIPSTICK STREP A
QUIDEL CORP.
QUICKVUE INFLUENZA A/B TEST
QUIDEL CORP.
QUICKVUE ONE-STEP H. PYLORI II TEST
QUIDEL CORP.
QUIDEL CH50 EQ EIA
QUIDEL CORP.
QUIDEL HOME PREGNANCY TEST
QUIDEL CORP.
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
QUIDEL CORP.
QUICKVUE SEMI-Q HCG-COMBO
QUIDEL CORP.
QUICKVUE ONE-STEP HCG-COMBO
QUIDEL CORP.
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
QUIDEL CORP.
CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO
QUIDEL CORP.
QUICKVUE ONE-STEP HCG-URINE
QUIDEL CORP.
CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE
QUIDEL CORP.
CARDS Q.S. STREP A
QUIDEL CORP.
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
QUIDEL CORP.
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
QUIDEL CORP.
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
QUIDEL CORP.
CAMEO HOME PREGNANCY TEST
QUIDEL CORP.
QUICKVUE ONE-STEP ALLERGEN SCREEN
QUIDEL CORP.
CONCEIVE OVULATION PREDICTOR
QUIDEL CORP.