Data / Medical devices / United States / Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc.: FDA-registered device maker in San Diego, CA, United States, 25 510(k) clearances
Ortho-Clinical Diagnostics, Inc. is registered with the FDA (registration 3033751096) in San Diego, CA, United States. It lists 20 device types. The FDA files 25 510(k) clearances under its listings, the newest dated March 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033751096
- Address
- 9975 Summers Ridge Rd, San Diego, CA, United States, 92121
- Owner or operator
- QuidelOrtho Corporation (2024674)
- Roles
- Complaint file establishment, Manufacturer for export, Specification developer
- First device listed
- December 22, 1992
- Registered through
- 2026
- Brand names listed
- CVS Health At Home COVID-19 Test Kit, InflammaDry, QUICKVUE IFOB TEST, QuickVue Adenoviral conjunctivitis Test, QuickVue At Home COVID-19, QuickVue COVID-19 Test, QuickVue Dipstick Strep A, QuickVue In-Line Strep A and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 22, 2024 | K231795 | QuickVue COVID-19 Test | QYT | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| December 13, 2023 | K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | QVF | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| March 8, 2023 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | QVF | Unknown | Quidel Corporation | accessdata.fda.gov |
| November 23, 2021 | K211342 | Sofia 2 Campylobacter FIA | LQP | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| August 30, 2018 | K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | LSR | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| October 20, 2017 | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | LSR | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| February 22, 2017 | K162911 | Sofia RSV FIA on Sofia 2 analyzer | GQG | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| December 16, 2014 | K141775 | SOFIA (R) STREP A+ FIA | GTY | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| November 21, 2013 | K132066 | INFLAMMA DRY | PFQ | Substantially Equivalent | Rapid Pathogen Screening, Inc. | accessdata.fda.gov |
| August 13, 2013 | K130398 | SOFIA(R) RSV FIA | GQG | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| October 24, 2011 | K112177 | SOFIA ANALYZER AND INFLUENZA A+B FIA | PSZ | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| May 17, 2011 | K110722 | RPS ADENO DETECTOR PLUS | GOD | Substantially Equivalent | Rapid Pathogen Screening, Inc. | accessdata.fda.gov |
| April 23, 2007 | K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 | GQG | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| December 14, 2005 | K053146 | QUICKVUE INFLUENZA A + B TEST | PSZ | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| June 17, 2002 | K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 17, 2002 | K020801 | QUICKVUE ONE-STEP HCG-COMBO | JHI | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| May 17, 2002 | K020799 | QUICKVUE ONE-STEP HCG-URINE | JHI | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| May 8, 2001 | K011097 | QUICKVUE DIPSTICK STREP A | GTY | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| November 26, 1997 | K974108 | SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) | JJX | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| November 26, 1997 | K973858 | CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO | JHI | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| April 15, 1996 | K955108 | CARDS Q.S. STREP A | GTZ | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| February 10, 1995 | K945080 | QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS) | GTY | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| July 18, 1994 | K934484 | QUICKVUE IN-LINE ONE-STEP STREP A TEST | GTZ | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| June 22, 1993 | K931761 | QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) | JJX | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| August 7, 1991 | K912868 | GROUP A STREP POSITIVE AND NEGATIVE CONTROLS | GTZ | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
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Updated March 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.