Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Ortho Clinical Diagnostics Inc. (QuidelOrtho) · Microbiology
Open FDA's page for this record- Third party flag
- N
- City
- San Diego
- Advisory committee description
- Microbiology
- Address 1
- 9975 Summers Ridge Rd.
- Statement or summary
- Summary
- Product code
- PSZ
- Zip code
- 92121
- Applicant
- Ortho Clinical Diagnostics Inc. (QuidelOrtho)
- Decision date
- 2026-09-04
- Decision code
- SESE
- Country code
- US
- Device name
- Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
- Advisory committee
- MI
- Contact
- Marisa Pugliese
- K number
- K254262
- State
- CA
- Date received
- 2025-12-30
- Review advisory committee
- MI
- Postal code
- 92121
- Decision description
- Substantially Equivalent
- Clearance type
- Dual Track
- Harmonized identifiers (openFDA)
- Device name
- Devices Detecting Influenza A, B, And C Virus Antigens
- Medical specialty description
- Microbiology
- Regulation number
- 866.3328
- Device class
- 2
- Registration number
- 3043196750, 3003750284, 1524213, 3026565854, 3018786392, 3013557562, 3026664926, 3014684020, 2030538, 3029906631, 3007886372, 3003917514, 2435505, 3013332582, 2029372, 3026478115, 1924669, 2431980, 3005174594, 3005984081, 3005586126, 3012494290, 1221359, 3026478116, 1649661, 3002792284, 3024753119, 2024674, 3033507883, 3010082909, 3014579161, 3033751096, 3006948883, 3010381606, 1119779, 3021090658, 3017772438, 3017662853, 1645225, 2246703
- FEI number
- 3043196750, 3003750284, 1000306617, 1524213, 3026565854, 3018786392, 3013557562, 3026664926, 3014684020, 3029906631, 3007886372, 3003917514, 3013332582, 1924669, 3026478115, 2431980, 3005174594, 3005984081, 3005586126, 3012494290, 1221359, 3026478116, 3002792284, 3024753119, 2024674, 3033507883, 3010082909, 3014579161, 3033751096, 3006948883, 3010381606, 1119779, 3021090658, 1000119795, 1000118544, 3001451797, 1000520007, 3017772438, 3017662853, 2246703