Company ยท US
Quidel Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2024. Name variants (Inc, Corp, punctuation) are merged.
130510(k) clearances (0 in 12 months)
15recalls (1 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 21 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 10 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 9 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 9 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 8 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 7 |
| LYR | Helicobacter Pylori | 6 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 6 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 4 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 4 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
| DGC | Ige, Antigen, Antiserum, Control | 3 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 3 |
| LSR | Reagent, Borrelia Serological Reagent | 3 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | 3 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 3 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 3 |
| PFQ | Mmp-9 Test System | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2024 | K231795 | QuickVue COVID-19 Test Quidel Corporation | QYT |
| Dec 20, 2023 | K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument Quidel Corporation | PGI |
| Dec 13, 2023 | K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set Quidel Corporation | QVF |
| Mar 10, 2023 | K230349 | Lyra RSV+hMPV Assay Quidel Corporation | OEM |
| Mar 8, 2023 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set Quidel Corporation | QVF |
| Mar 3, 2023 | K230236 | Lyra Influenza A+B Assay Quidel Corporation | OZE |
| Nov 23, 2021 | K211342 | Sofia 2 Campylobacter FIA Quidel Corporation | LQP |
| Aug 30, 2018 | K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set Quidel Corporation | LSR |
| Jul 15, 2018 | K181029 | Solana Bordetella Complete Assay Quidel Corporation | OZZ |
| Feb 28, 2018 | K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack Quidel Corporation | LSR |
| Feb 13, 2018 | K180288 | QuickVue Influenza A+B Quidel Corporation | PSZ |
| Dec 21, 2017 | K173250 | Solana GBS Assay Quidel Corporation | NJR |
| Dec 21, 2017 | K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer Quidel Corporation | GTY |
| Oct 20, 2017 | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set Quidel Corporation | LSR |
| Oct 16, 2017 | K171974 | Solana RSV+hMPV Assay Quidel Corporation | OCC |
| May 11, 2017 | K170491 | Solana C. difficile Assay Quidel Corporation | OZN |
| Apr 14, 2017 | K162438 | Sofia Influenza A+B FIA on Sofia 2 Quidel Corporation | PSZ |
| Feb 22, 2017 | K162911 | Sofia RSV FIA on Sofia 2 analyzer Quidel Corporation | GQG |
| Nov 28, 2016 | K162451 | Solana HSV 1+2/VZV Assay Quidel Corporation | PGI |
| Oct 25, 2016 | K162274 | Solana Strep Complete Assay Quidel Corporation | PGX |
| Sep 27, 2016 | K161814 | Solana Influenza A+B Assay Quidel Corporation | OCC |
| Aug 15, 2016 | K161182 | Solana Trichomonas Assay Quidel Corporation | OUY |
| Jan 12, 2016 | K153012 | Sofia Influenza A+B FIA Quidel Corporation | PSZ |
| Jun 23, 2015 | K150868 | Solana GAS Assay, Solana instrument Quidel Corporation | PGX |
| Mar 17, 2015 | K143329 | AmpliVue Trichomonas Assay Quidel Corporation | OUY |
| Dec 16, 2014 | K141775 | SOFIA (R) STREP A+ FIA Quidel Corporation | GTY |
| Dec 10, 2014 | K143206 | AmpliVue Bordetella Assay Quidel Corporation | OZZ |
| Oct 9, 2014 | K141931 | LYRA ADENOVIRUS ASSAY Quidel Corporation | OCC |
| Oct 9, 2014 | K141927 | LYRA PARAINFLUENZA VIRUS ASSAY Quidel Corporation | OOU |
| Jul 24, 2014 | K141173 | AMPLIVUE GAS ASSAY Quidel Corporation | PGX |
| Apr 16, 2014 | DEN140005 | LYRA DIRECT STREP ASSAY Quidel Corporation | PGX |
| Mar 26, 2014 | K140029 | AMIPLIVUE HSV 1&2 ASSAY Quidel Corporation | OQO |
| Dec 20, 2013 | K133503 | AMPLIVUE GBS ASSAY Quidel Corporation | NJR |
| Sep 6, 2013 | K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY Quidel Corp. | OCC |
| Aug 29, 2013 | K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY Quidel Corp. | OZE |
| Aug 13, 2013 | K130398 | SOFIA(R) RSV FIA Quidel Corp. | GQG |
| Aug 2, 2013 | K131166 | SOFIA(R) HCG FIA Quidel Corp. | JHI |
| Jul 5, 2013 | K131606 | SOFIA INFLUENZA A+B FIA Quidel Corp. | GNX |
| Jul 5, 2013 | K131599 | QUICK VUE INFLUENZA Quidel Corporation | GNX |
| Jun 28, 2013 | K131619 | QUICKVUE INFLUENZA A+B Quidel Corp. | GNX |
| Jun 17, 2013 | K123793 | SOFIA STREP A FIA Quidel Corporation | GTY |
| Mar 8, 2013 | K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY Quidel Corp. | OZN |
| Mar 8, 2013 | K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY Quidel Corp. | OEM |
| Dec 13, 2012 | K123355 | AMPLIVUE C. DIFFICILE ASSAY Quidel Corporation | OZN |
| Mar 15, 2012 | K113777 | QUIDEL MOLECULAR INFLUENZA A+B Quidel Corp. | OZE |
| Dec 22, 2011 | K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY Quidel Corp. | OCC |
| Dec 15, 2011 | K112490 | QUIDEL MOLECULAR HMPV ASSAY Quidel Corp. | OEM |
| Oct 24, 2011 | K112177 | SOFIA ANALYZER AND INFLUENZA A+B FIA Quidel Corp. | PSZ |
| Sep 24, 2010 | K101918 | QUICKVUE RSV 10 Quidel Corp. | GQG |
| Aug 25, 2010 | K102175 | RAPIDVUE HCG TEST Quidel Corporation | JHI |
Newest 50 of 130.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Quidel Corporation QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. Open, Classified |
GTY | K011097 |
| Sep 10, 2025 | Quidel Corporation QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC Open, Classified |
GTY | K011097 |
| Apr 24, 2024 | Quidel Corporation QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests Open, Classified |
PFQ | K132066 |
| Apr 24, 2024 | Quidel Corporation QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests Open, Classified |
PFQ | K132066 |
| Feb 14, 2024 | Quidel Corporation The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. Th Open, Classified |
QMN | None listed |
| Mar 30, 2023 | Quidel Corporation MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 Open, Classified |
DBA | K872426 |
| Aug 13, 2021 | Quidel Corporation Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization-
Ref: M124.
The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV- Terminated |
QJR | None listed |
| Jun 26, 2021 | Quidel Corporation Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent Terminated |
QJR | None listed |
| Sep 25, 2020 | Quidel Corporation QUIDEL Sofia SARS Antigen FIA IVD REF 20374 Terminated |
PSZ | None listed |
| Sep 17, 2020 | Quidel Corporation Sofia SARS Antigen FIA Package Insert
The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative de Terminated |
QKP | None listed |
| Dec 15, 2017 | Quidel Corporation Sofia 2 Analyzer Catalog Number 20299
Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and Terminated |
PSZ | K162438 K162911 |
| Jun 22, 2017 | Quidel Corporation InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors
InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in hum Terminated |
PFQ | K132066 |
| Feb 22, 2017 | Quidel Corporation Influenza Transport Swab Packages, Reference #20171,
One lot with 1010 packages (each package contains 25 transport tubes).
The Influenza Swabs in dry transport tubes are intended for use with influe Terminated |
OCC | K141520 |
| Feb 14, 2013 | Quidel Corporation Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. Terminated |
GNX | K112177 |
| Mar 1, 2011 | Quidel Corporation QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842 Terminated |
JHI | K020799 |