Brand Name | ARCHITECT SYPHILIS TP REAGENT KIT |
Type of Device | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM |
Manufacturer (Section D) |
ABBOTT GMBH |
max-planck-ring 2 |
wiesbaden 65205 |
GM 65205 |
|
Manufacturer (Section G) |
ABBOTT GMBH |
max-planck-ring 2 |
|
wiesbaden 65205 |
GM
65205
|
|
Manufacturer Contact |
nicole
jenne
|
max-planck-ring 2 |
post market surveillance |
wiesbaden 65205
|
GM
65205
|
6122582960
|
|
MDR Report Key | 19148906 |
MDR Text Key | 341001475 |
Report Number | 3002809144-2024-00123 |
Device Sequence Number | 1 |
Product Code |
LIP
|
UDI-Device Identifier | 00380740161934 |
UDI-Public | (01)00380740161934(17)240907(10)57034BE01 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K153730 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/19/2024 |
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 Catalogue Number | 08D06-77 |
Device Lot Number | 57034BE01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/19/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ARC I2000SR INST, 03M74-02, (B)(6) |