FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
K Number: DEN220039
·
Decision Mar 8, 2023
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
37
Review Days
265
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Basic Information
- Device Name
- Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
- K Number
- DEN220039
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.3982
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Quidel Corporation
- Date Received
- June 16, 2022
- Decision Date
- March 8, 2023
- Product Code
- QVF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | FDA class 2 | Microbiology |
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Other Clearances by Quidel Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K231795 | QuickVue COVID-19 Test | Mar 22, 2024 | Substantially Equivalent |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | Dec 20, 2023 | Substantially Equivalent |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Dec 13, 2023 | Substantially Equivalent |
| K230349 | Lyra RSV+hMPV Assay | Mar 10, 2023 | Substantially Equivalent |
| K230236 | Lyra Influenza A+B Assay | Mar 3, 2023 | Substantially Equivalent |
| K211342 | Sofia 2 Campylobacter FIA | Nov 23, 2021 | Substantially Equivalent |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | Aug 30, 2018 | Substantially Equivalent |
| K181029 | Solana Bordetella Complete Assay | Jul 15, 2018 | Substantially Equivalent |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Feb 28, 2018 | Substantially Equivalent |
| K180288 | QuickVue Influenza A+B | Feb 13, 2018 | Substantially Equivalent |