Brand Name | AIA-360 |
Type of Device | FLUOROMETER, FOR CLINICAL USE |
Manufacturer (Section D) |
TOSOH HI-TEC, INC. |
1-37, fukugawa minami-machi |
shunan, yamaguchi 74600 42 |
JA 7460042 |
|
Manufacturer (Section G) |
TOSOH HI-TEC, INC. |
1-37, fukugawa minami-machi |
|
shunan, yamaguchi 74600 42 |
JA
7460042
|
|
Manufacturer Contact |
jorge
porras
|
shiba-koen first building |
3-8-2 shiba |
minato-ku 10586-23
|
JA
1058623
|
6506368314
|
|
MDR Report Key | 17276198 |
MDR Text Key | 318605558 |
Report Number | 3004529019-2023-00363 |
Device Sequence Number | 1 |
Product Code |
KHO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K971103 |
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 |
07/07/2023 |
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 |
Health Professional
|
Device Model Number | AIA-360 IMMUNOASSAY ANALYZER |
Device Catalogue Number | 019945 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/19/2023
|
Initial Date FDA Received | 07/06/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/01/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |