Brand Name | CELLTRION DIATRUST COVID-19 AG HOME TEST |
Type of Device | IN VITRO DIAGNOSTICS |
Manufacturer (Section D) |
HUMASIS CO., LTD. |
88, jeonpa-ro, dongan-gu |
anyang-si |
gyeonggi-do, 14042 |
KS 14042 |
|
MDR Report Key | 13419232 |
MDR Text Key | 286767761 |
Report Number | 3008719759-2022-00023 |
Device Sequence Number | 1 |
Product Code |
QKP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/21/2022,01/25/2022 |
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 Expiration Date | 11/26/2022 |
Device Lot Number | COVSD1003 |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 01/09/2022 |
Event Location |
Home
|
Date Report to Manufacturer | 01/21/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/01/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|