Brand Name | ELECSYS CA 19-9 IMMUNOASSAY |
Type of Device | TEST, CARBOHYDRATE ANTIGEN (CA19-9) |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 |
|
Manufacturer (Section G) |
ROCHE DIAGNOSTICS GMBH |
sandhofferstrasse 116 |
na |
mannheim (baden-wurttemberg), na 68305 |
GM
68305
|
|
Manufacturer Contact |
michael
leslie
|
9115 hague road |
na |
indianapolis, IN 46250
|
3175214343
|
|
MDR Report Key | 8284312 |
MDR Text Key | 134752740 |
Report Number | 1823260-2019-90021 |
Device Sequence Number | 1 |
Product Code |
NIG
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Type of Report
| Initial,Followup |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 01/29/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Model Number | CA 19-9 |
Device Catalogue Number | 11776193122 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No Answer Provided
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Was Device Evaluated by Manufacturer? |
No Answer Provided
|
Is the Device Single Use? |
No Answer Provided
|
Is This a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
|
|
|