Identity
- Trade Name
- Sofia FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
- Device Name
- Sofia Analyzer, Reconditioned FDA UDI
- Model / Reference
- 20221R FDA UDI
- Description
- Sofia Analyzer, Reconditioned FDA UDI
Identifiers
- Catalog Number
- 20221R FDA UDI
- Primary DI / UDI-DI
- 30014613802211 FDA UDI
- 510(k) Number
- K112177 FDA UDI
- FDA Product Code
- KHO FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fluorescent immunoassay analyser IVD, point-of-care
Sofia by Quidel Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluorescent immunoassay analyser IVD, point-of-care.
- Fluoro-CheckerTM TRF Reader — Nano-Ditech Corporation
- Triage — Quidel Cardiovascular Inc. · Class II
- Triage — Quidel Cardiovascular Inc. · Class II
- ASFA® SCANNER — MBD CO., Ltd. · Class I
- RAMP® 200 TM Test Module — Response Biomedical Corp. · Class I
- Sofia — Quidel Corp. · Class I
- Sofia — Quidel Corp. · Class I
- Sofia — Quidel Corp. · Class I
Cleared under the same submission
K112177 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA UDI 6245819c-ab4c-4ea6-807c-b2618b7beaf6 36 fields · synced May 30, 2026