Brand Name | SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB |
Type of Device | SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB |
Manufacturer (Section D) |
QUIDELORTHO CORPORATION |
10165 mckellar court |
san diego CA 92121 |
|
Manufacturer Contact |
karl
luke
|
10165 mckellar court |
san diego, CA 92121
|
|
MDR Report Key | 18966148 |
MDR Text Key | 338610544 |
Report Number | 0002024674-2024-00198 |
Device Sequence Number | 1 |
Product Code |
QMN
|
UDI-Device Identifier | 30014613339229 |
UDI-Public | 30014613339229 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EUA202751 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/22/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/23/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 20377 |
Device Lot Number | 709092 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/26/2024 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|