Brand Name | FLOWFLEX COVID-19 ANTIGEN HOME TEST |
Type of Device | ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP |
Manufacturer (Section D) |
ACON LABORATORIES, INC. |
5850 oberlin drive #340 |
san diego CA 92121 |
|
Manufacturer (Section G) |
ACON LABORATORIES, INC. |
5850 oberlin drive #340 |
|
san diego CA 92121 |
|
Manufacturer Contact |
qiyi
xie
|
5850 oberlin drive #340 |
san diego, CA 92121
|
8588758011
|
|
MDR Report Key | 16382243 |
MDR Text Key | 309613257 |
Report Number | 2531491-2023-00272 |
Device Sequence Number | 1 |
Product Code |
QKP
|
Combination Product (y/n) | N |
PMA/PMN Number | EUA210494 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/15/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/08/2023
|
Initial Date FDA Received | 02/15/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |