FDA UDI
In Commercial Distribution
🇺🇸 United States
Sofia
DI: 30014613336341
·
Model: 20299
·
QUIDEL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sofia
- Primary DI
- 30014613336341
- Version / Model
- 20299
- Catalog Number
- 20299
- Company Name
- QUIDEL CORPORATION
- Labeler DUNS
- 079509836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-21
- Public Version
- 4
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- e3ff4f23-2613-490d-8967-92d0590f637b
Device Description
Sofia Analyzer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHO | FLUOROMETER, FOR CLINICAL USE | Clinical Chemistry | 862.2560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48014 | Fluorescent immunoassay analyser IVD, point-of-care | A portable, electrically-powered instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative, and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care and in the laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30014613336341 | GS1 |
Customer Contacts
- Phone
- +1(858)552-1100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162911 | 000 |