Brand Name | VITEK® 2 AST-N366 TEST KIT |
Type of Device | VITEK® 2 AST-N366 TEST KIT |
Manufacturer (Section D) |
BIOMERIEUX, INC. |
595 anglum road |
hazelwood MO 63042 |
|
Manufacturer (Section G) |
BIOMERIEUX, INC. |
595 anglum road |
|
hazelwood MO 63042 |
|
Manufacturer Contact |
candace
martin
|
595 anglum road |
hazelwood, MO 63042
|
|
MDR Report Key | 8203882 |
MDR Text Key | 131768749 |
Report Number | 1950204-2018-00732 |
Device Sequence Number | 1 |
Product Code |
LON
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | N50510: S82 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/28/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/28/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/02/2019 |
Device Catalogue Number | 421853 |
Device Lot Number | 8160736403 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/21/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/02/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |