# Quidel Corp.

- Location (FDA's records): San Diego, CA
- FDA decisions: 131 (1983–2024): 128 510(k) clearances, 2 De Novo grants and 1 original PMA approval
- Names in FDA's records: Quidel Corp. (94); Quidel Corporation (37)
- Product codes: JHI (20), LCX (9), DHB (9), PSZ (8), GTZ (8), LYR (6), JJX (5), GTY (5), OCC (5), GQG (4), PGX (4), DGC (3)
- 510(k) review time since 2016: median 99 days, against 92 for FDA's reviews in the same codes and years (5 of 12 faster)
- Predicates its devices cite: 62 (34 its own); citations of its devices by later devices: 74 (34 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Prodesse, Inc.: 9 (https://510kreport.com/company/prodesse)
- bioMerieux, Inc.: 4 (https://510kreport.com/company/biomerieux)
- Meridian Bioscience, Inc.: 2 (https://510kreport.com/company/meridian-bioscience)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Thermo Biostar, Inc.: 1 (https://510kreport.com/company/thermo-biostar)
- Binax, Inc.: 1 (https://510kreport.com/company/binax)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Argene SA: 1 (https://510kreport.com/company/argene)

## Firms that cite its devices most
- Becton, Dickinson & CO: 8 (https://510kreport.com/company/becton-dickinson)
- Binax, Inc.: 3 (https://510kreport.com/company/binax)
- Ortho-Clinical Diagnostics, Inc. (QuidelOrtho): 3 (https://510kreport.com/company/ortho-clinical-diagnostics-quidelortho)
- Alere Scarborough, Inc.: 2 (https://510kreport.com/company/alere-scarborough)
- Abbott Diagnostics Scarborough, Inc.: 2 (https://510kreport.com/company/abbott-diagnostics-scarborough)
- Genzyme Corp.: 2 (https://510kreport.com/company/genzyme)
- ACON Laboratories, Inc.: 2 (https://510kreport.com/company/acon-laboratories)
- Arbor Vita Corportation: 1 (https://510kreport.com/company/arbor-vita-corportation)

## Its most-cited devices
- K053146: Quickvue Influenza a + B Test (2005), cited by 6
- DEN140005: Lyra Direct Strep Assay (2014), cited by 6
- DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (2023), cited by 5
- K031899: Quickvue Influenza a+B Test (2003), cited by 4
- K991633: Quickvue Influenza a/B Test (1999), cited by 4
- K092698: Quickvue Influenza a+B Test (2009), cited by 3

## Recent decisions
- K231795: QuickVue COVID-19 Test (Mar 22, 2024)
- K232286: Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (Dec 20, 2023)
- K233688: Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (Dec 13, 2023)
- K230349: Lyra RSV+hMPV Assay (Mar 10, 2023)
- DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (Mar 8, 2023)
- K230236: Lyra Influenza A+B Assay (Mar 3, 2023)
- K211342: Sofia 2 Campylobacter FIA (Nov 23, 2021)
- K173496: Sofia 2 Lyme FIA, Sofia Lyme Control Set (Aug 30, 2018)

Source page: https://510kreport.com/company/quidel