Quidel Corp.
Medical device manufacturer in San Diego, CA.
128510(k) clearances
1PMA approvals
15recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 20
- DHB System, Test, Radioallergosorbent (Rast)… 9
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 9
- GTZ Antisera, All Groups, Streptococcus Spp. 8
- PSZ Devices Detecting Influenza A, B, And C… 8
- LYR Helicobacter Pylori 6
- OCC Respiratory Virus Panel Nucleic Acid Assay… 5
- JJX Single (Specified) Analyte Controls… 5
- GTY Antigens, All Groups, Streptococcus Spp. 5
- GQG Antigen, Cf (Including Cf Controls)… 4
- LSR Reagent, Borrelia Serological Reagent 3
- OEM Human Metapneumovirus (Hmpv) Rna Assay System 3
- OZE Influenza A And Influenza B Multiplex… 3
- OZN C. Difficile Toxin Gene Amplification Assay 3
- GNX Antigens, Cf (Including Cf Control)… 3
- LJC Enzyme Linked Immunoabsorbent Assay… 3
- DGC Ige, Antigen, Antiserum, Control 3
- CEP Radioimmunoassay, Luteinizing Hormone 3
- PGX Groups A, C And G Beta-Hemolytic… 3
- KTN System, Test, Infectious Mononucleosis 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K231795 | QuickVue COVID-19 TestQYT · Traditional | 03/22/2024SE |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentPGI · Traditional | 12/20/2023SE |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF · Special | 12/13/2023SE |
| K230349 | Lyra RSV+hMPV AssayOEM · Special | 03/10/2023SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | 03/03/2023SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | 11/23/2021SE |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR · Dual Track | 08/30/2018SE |
| K181029 | Solana Bordetella Complete AssayOZZ · Traditional | 07/15/2018SE |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | 02/28/2018SE |
| K180288 | QuickVue Influenza A+BPSZ · Special | 02/13/2018SE |
| K173250 | Solana GBS AssayNJR · Traditional | 12/21/2017SE |
| K171976 | Sofia Strep A+ FIA, Sofia 2 AnalyzerGTY · Dual Track | 12/21/2017SE |
| K163713 | Sofia Lyme FIA, Sofia Lyme Control SetLSR · Traditional | 10/20/2017SE |
| K171974 | Solana RSV+hMPV AssayOCC · Traditional | 10/16/2017SE |
| K170491 | Solana C. difficile AssayOZN · Traditional | 05/11/2017SE |
| K162438 | Sofia Influenza A+B FIA on Sofia 2PSZ · Traditional | 04/14/2017SE |
| K162911 | Sofia RSV FIA on Sofia 2 analyzerGQG · Traditional | 02/22/2017SE |
| K162451 | Solana HSV 1+2/VZV AssayPGI · Traditional | 11/28/2016SE |
| K162274 | Solana Strep Complete AssayPGX · Traditional | 10/25/2016SE |
| K161814 | Solana Influenza A+B AssayOCC · Traditional | 09/27/2016SE |
| K161182 | Solana Trichomonas AssayOUY · Traditional | 08/15/2016SE |
| K153012 | Sofia Influenza A+B FIAPSZ · Traditional | 01/12/2016SE |
| K150868 | Solana GAS Assay, Solana instrumentPGX · Traditional | 06/23/2015SE |
| K143329 | AmpliVue Trichomonas AssayOUY · Traditional | 03/17/2015SE |
| K141775 | Sofia (R) Strep A+ FiaGTY · Dual Track | 12/16/2014SE |
| K143206 | AmpliVue Bordetella AssayOZZ · Traditional | 12/10/2014SE |
| K141931 | Lyra Adenovirus AssayOCC · Traditional | 10/09/2014SE |
| K141927 | Lyra Parainfluenza Virus AssayOOU · Traditional | 10/09/2014SE |
| K141173 | Amplivue Gas AssayPGX · Traditional | 07/24/2014SE |
| K140029 | Amiplivue HSV 1&2 AssayOQO · Traditional | 03/26/2014SE |
| K133503 | Amplivue GBS AssayNJR · Traditional | 12/20/2013SE |
| K131813 | Quidel Molecular RSV + HMPV AssayOCC · Traditional | 09/06/2013SE |
| K131728 | Quidel Molecular Influenza a + B AssayOZE · Traditional | 08/29/2013SE |
| K130398 | Sofia(R) RSV FiaGQG · Traditional | 08/13/2013SE |
| K131166 | Sofia(R) HCG FiaJHI · Traditional | 08/02/2013SE |
| K131606 | Sofia Influenza A+B FiaGNX · Special | 07/05/2013SE |
| K131599 | Quick Vue InfluenzaGNX · Special | 07/05/2013SE |
| K131619 | Quickvue Influenza A+BGNX · Special | 06/28/2013SE |
| K123793 | Sofia Strep a FiaGTY · Traditional | 06/17/2013SE |
| K123998 | Quidel Molecular Direct C. Difficile AssayOZN · Traditional | 03/08/2013SE |
| K122189 | Quidel Molecular RSV + HMPV AssayOEM · Traditional | 03/08/2013SE |
| K123355 | Amplivue C. Difficile AssayOZN · Traditional | 12/13/2012SE |
| K113777 | Quidel Molecular Influenza A+BOZE · Traditional | 03/15/2012SE |
| K112172 | Quidel Molecular Influenza a + B AssayOCC · Traditional | 12/22/2011SE |
| K112490 | Quidel Molecular HMPV AssayOEM · Traditional | 12/15/2011SE |
| K112177 | Sofia Analyzer and Influenza A+B FiaPSZ · Traditional | 10/24/2011SE |
| K101918 | Quickvue RSV 10GQG · Traditional | 09/24/2010SE |
| K102175 | Rapidvue HCG TestJHI · Special | 08/25/2010SE |
| K092698 | Quickvue Influenza A+B TestPSZ · Special | 09/15/2009SE |
| K070747 | Quick Vue RSV Test, Models 20193, 20199GQG · Traditional | 04/23/2007SE |
| K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199MCE · Traditional | 09/08/2006SE |
| K053146 | Quickvue Influenza a + B TestPSZ · Traditional | 12/14/2005SE |
| K040008 | Quickvue Advance PH and Amines GLL TestCEN · Traditional | 04/29/2004SE |
| K031899 | Quickvue Influenza A+B TestPSZ · Traditional | 09/11/2003SE |
| K022851 | PH and Amines External Control SetJJY · Traditional | 09/27/2002SE |
| K020801 | Quickvue One-Step Hcg-ComboJHI · Traditional | 05/17/2002SE |
| K020799 | Quickvue One-Step Hcg-UrineJHI · Traditional | 05/17/2002SE |
| K011097 | Quickvue Dipstick Strep aGTY · Traditional | 05/08/2001SE |
| K991633 | Quickvue Influenza A/B TestPSZ · Traditional | 09/24/1999SE |
| K991747 | Quickvue One-Step H. Pylori II TestLYR · Traditional | 08/04/1999SE |
| K974111 | Quidel CH50 Eq EiaDAE · Traditional | 07/29/1998SE |
| K981722 | Quidel Home Pregnancy TestLCX · Traditional | 06/03/1998SE |
| K974821 | Bluetest(R) Pregnancy Test, Rapidvue(R) Pregnancy TestLCX · Traditional | 01/26/1998SE |
| K974052 | Quickvue Semi-Q Hcg-ComboJHI · Traditional | 12/19/1997SE |
| K973841 | Quickvue One-Step Hcg-ComboJHI · Traditional | 12/01/1997SE |
| K974108 | Serum HCG Control Set (Negative, Low Positive and High Positive)JJX · Traditional | 11/26/1997SE |
| K973858 | Cards Q.S. HCG Serum/Urine;Concise Performance Plus Hcg-ComboJHI · Traditional | 11/26/1997SE |
| K972748 | Cards Q.S. Hcg-Urine; and Concise Performance Plus Hcg-UrineJHI · Traditional | 08/29/1997SE |
| K972742 | Quickvue One-Step Hcg-UrineJHI · Traditional | 08/29/1997SE |
| K955108 | Cards Q.S. Strep aGTZ · Traditional | 04/15/1996SE |
| K952517 | Quickvue One-Step Helicobactor Pylori TestLYR · Traditional | 02/06/1996SE |
| K954257 | Quickvue In-Line One Step Strep a Test (Modification)GTZ · Traditional | 10/20/1995SE |
| K954273 | Cards Q.S. HCG or Concise Performance Plus HCGJHI · Traditional | 10/16/1995SE |
| K954364 | Cameo Home Pregnancy TestLCX · Traditional | 10/13/1995SE |
| K950728 | Quickvue One-Step Allergen ScreenDHB · Traditional | 10/02/1995SE |
| K953063 | Conceive Ovulation PredictorCEP · Traditional | 08/23/1995SE |
| K946276 | Quickvue(R) Chlamydia TestLJC · Traditional | 05/19/1995SE |
| K945080 | Quickvue In-Line One-Step Strep a Control Swabs (Positive & Negative Swab Specimens)GTY · Traditional | 02/10/1995SE |
| K945969 | Rapidvue(Tm) HCGJHI · Traditional | 01/27/1995SE |
| K934484 | Quickvue In-Line One-Step Strep a TestGTZ · Traditional | 07/18/1994SE |
| K932042 | Quickvue One-Step HCG ComboJHI · Traditional | 06/29/1993SE |
| K931761 | Quickvue(Tm) One-Step HCG Controls (Posit/Negati)JJX · Traditional | 06/22/1993SE |
| K925096 | Conceive One-Step Pregnancy TestLCX · Traditional | 12/28/1992SE |
| K925435 | Quickvue One-Step HCG TestJHI · Traditional | 12/03/1992SE |
| K920160 | LH Gen III Self-Test/ConceiveCEP · Traditional | 03/11/1992SE |
| K915851 | Quidel Quickvue H. Pylori Controls (Pos. and Neg)LYR · Traditional | 02/21/1992SE |
| K912442 | Quidel Helicobacter Pylori Microwell Eia TestLYR · Traditional | 09/16/1991SE |
| K913122 | Directigen 1-2-3(TM) HCG TestJHI · Traditional | 08/16/1991SE |
| K912868 | Group a Strep Positive and Negative ControlsGTZ · Traditional | 08/07/1991SE |
| K911664 | Directigen 1-2-3 Pregnancy ControlsJJX · Traditional | 05/31/1991SE |
| K905049 | Quidel Helicobacter Pylori Postive/Negative ContrLYR · Traditional | 05/07/1991SE |
| K903099 | Quidel Helicobacter Pylori TestLYR · Traditional | 04/17/1991SE |
| K910082 | Positive Control Pad for Total Ige Test DipstickDGC · Traditional | 03/12/1991SE |
| K905162 | Quidel Total Ige Positive Control SerumDHB · Traditional | 01/14/1991SE |
| K905176 | Positive Control Pad Allergen/Food Allergen ScreenDHB · Traditional | 12/13/1990SE |
| K903738 | Quidel Allergen Screen Positive ControlDGC · Traditional | 10/15/1990SE |
| K903765 | Quidel Chlamydia Positive ControlLJC · Traditional | 10/02/1990SE |
| K901660 | Quidel Chlamydia TestLJC · Traditional | 07/27/1990SE |
| K896265 | Quidel Group B Strep TestGTZ · Traditional | 02/16/1990SE |
| K896926 | Directigen 1-2-3 Infectious Mononucleosis ControlsKTN · Traditional | 01/26/1990SE |
| K894790 | Quidel HCG TestJHI · Traditional | 10/25/1989SE |
| K893738 | Quidel Reflectance AnalyzerJJQ · Traditional | 08/11/1989SE |
| K894253 | Quidel Food Allergen ScreenDHB · Traditional | 07/28/1989SE |
| K894039 | Quidel Total Ige Test Quantitative VersionDGO · Traditional | 07/14/1989SE |
| K893737 | Directigen 1-2-3 Infectious Mononucleosis TestKTN · Traditional | 06/16/1989SE |
| K892409 | Quidel Food Allergen Screen - Barley AllergenDHB · Traditional | 05/04/1989SE |
| K890615 | DIRECTIGEN1-2-3 BHCG Pregnancy TestJHI · Traditional | 04/18/1989SE |
| K884501 | Quidel Food Allergy ScreenDHB · Traditional | 02/17/1989SE |
| K883666 | Quidel Allergy ScreenDHB · Traditional | 10/18/1988SE |
| K883999 | Quidel Group a Strep TestGTZ · Traditional | 10/12/1988SE |
| K883741 | Qtest Pregnancy Test ControlJJX · Traditional | 10/03/1988SE |
| K883316 | Quidel Pregnancy Test ControlJJX · Traditional | 09/22/1988SE |
| K882086 | Qtest(Tm) PregnancyJHI · Traditional | 07/28/1988SE |
| K881595 | Quidel Pregnancy TestJHI · Traditional | 05/27/1988SE |
| K874717 | Quidel Allergy ScreenDHB · Traditional | 04/06/1988SE |
| K875168 | Quidel Total Ige TestDHB · Traditional | 03/18/1988SE |
| K872961 | Qtest StrepGTZ · Traditional | 09/29/1987SE |
| K862207 | Quidel Beta Stick Pregnancy Test (Modification)LCX · Traditional | 06/17/1986SE |
| K861171 | Quidel Allergy ScreenDGC · Traditional | 04/25/1986SE |
| K852806 | Quidel Quest Strep Group a TestGTZ · Traditional | 07/30/1985SE |
| K852146 | Quidel Quest Ovulation TestCEP · Traditional | 07/29/1985SE |
| K844082 | Quest Beta HCG Enzyme Immunoassay KitJHI · Traditional | 11/21/1984SE |
| K842692 | Quidel Beta HCG Enzyme Immunoassay KitJHI · Traditional | 09/05/1984SE |
| K841415 | Beta Stick, Pregnancy TestLCX · Traditional | 07/11/1984SE |
| K833466 | Early Pregnancy Detection Test KitLCX · Traditional | 11/25/1983SE |
| K833156 | Quidel HCG Enzyme Immunoassay KitJHJ · Traditional | 11/25/1983SE |
| K831108 | Home Pregnancy Test KitLCX · Traditional | 05/18/1983SE |
| K831051 | Home Pregnancy Test Kit HPK #1LCX · Traditional | 05/18/1983SE |
PMA approvals
- P990039 QUS-2 (TM) Calcaneal Ultrasonometer · 08/01/2000 · 1 supplement
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2169-2026 Class II | QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Product has the potential for false positive results | 04/06/2026Open, Classified |
| Z-2545-2025 Class II | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SCDipstick strep A test has potential for false positive results. | 06/17/2025Open, Classified |
| Z-1637-2024 Class II | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 TestsThere are two windows on the test device, the control line window and the test results window. The line for… | 03/05/2024Open, Classified |
| Z-1636-2024 Class II | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 TestsThere are two windows on the test device, the control line window and the test results window. The line for… | 03/05/2024Open, Classified |
| Z-1086-2024 Class II | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich…One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The… | 01/03/2024Open, Classified |
| Z-1308-2023 Class II | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor…Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail… | 02/01/2023Open, Classified |
| Z-2477-2021 Class II | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct…Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be… | 08/13/2021Terminated |
| Z-1928-2021 Class I | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagentIn rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct… | 04/27/2021Terminated |
| Z-0428-2021 Class II | QUIDEL Sofia SARS Antigen FIA IVD REF 20374Due to false positive results. | 09/25/2020Terminated |
| Z-0124-2021 Class II | Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow…Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references… | 09/17/2020Terminated |
| Z-1183-2018 Class II | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be…The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process… | 12/15/2017Terminated |
| Z-2803-2017 Class II | InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid…In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. | 06/22/2017Terminated |
| Z-1231-2017 Class II | Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each…Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample… | 01/25/2017Terminated |
| Z-0819-2013 Class II | Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits… | 12/03/2012Terminated |
| Z-1457-2011 | QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG… | 11/23/2010Terminated |