Brand Name | COVID RAPID ANTIGEN TEST KIT AT HOME |
Type of Device | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. |
Manufacturer (Section D) |
IHEALTH LABS, INC. |
120 san lucar ct. |
sunnyvale, CA 94086 |
|
MDR Report Key | 13426298 |
MDR Text Key | 285223623 |
Report Number | MW5107161 |
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 |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
01/31/2022 |
2 Devices were Involved in the Event: |
1
2
|
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 | 06/23/2022 |
Device Model Number | GIN(01): 20856362005894 |
Device Catalogue Number | 20856362005894 |
Device Lot Number | (10): 213C021224-06 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/01/2022 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 52 YR |
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |
Patient Race | Asian, Black Or African American, White, American Indian Or Alaskan Native, Native Hawaiian Or Other Pacific Islander |
|
|